CAR PRACTICE GUIDELINES AND TECHNICAL STANDARDS FOR BREAST IMAGING AND INTERVENTION

APPROVED ON SEPTEMBER 29, 2012 CHAIR, SHIELA APPAVOO, MD; ANN ALDIS, MD; PETRINA CAUSER, MD; PAVEL CRYSTAL, MD; BENOÎT MESUROLLE, MD; YOLANDA MUNDT, MRT; NEETY PANU, MD; JEAN SEELY, MD; NANCY WADDEN, MD

MODIFIED ON SEPTEMBER 17, 2016: CHAIR, SHIELA APPAVOO, MD; ANN ALDIS, MD; PETRINA CAUSER, MD; PAVEL CRYSTAL, MD; ANAT KORNECKI, MD; YOLANDA MUNDT, MRT; JEAN SEELY, MD; NANCY WADDEN, MD The practice guidelines of the Canadian Association of Radiologists (CAR) are not rules, but are guidelines that attempt to define principles of practice that should generally produce radiological care. The radiologist and medical physicist may modify an existing practice guideline as determined by the individual patient and available resources. Adherence to CAR practice guidelines will not assure a successful outcome in every situation. The practice guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The practice guidelines are not intended to establish a legal standard of care or conduct, and deviation from a practice guideline does not, in and of itself, indicate or imply that such medical practice is below an acceptable level of care. The ultimate judgment regarding the propriety of any specific procedure or course of conduct must be made by the physician and medical physicist in light of all circumstances presented by the individual situation.

Approved on September 29, 2012

Chair, Shiela Appavoo, MD; Ann Aldis, MD; Petrina Causer, MD; Pavel Crystal, MD; Benoît Mesurolle, MD; Yolanda Mundt, MRT; Neety Panu, MD; Jean Seely, MD; Nancy Wadden, MD

ModifiedChair, Shiela On Appavoo,September MD 17,; Ann 2016: Aldis, MD; Petrina Causer, MD; Pavel Crystal, MD; Anat Kornecki, MD; Yolanda Mundt, MRT; Jean Seely, MD; Nancy Wadden, MD

ii TABLE OF CONTENTS

Preamble ...... 3 Section A: Breast Imaging...... 4 1. Mammography...... 4 1.1. Screening Mammography...... 4 ...... 4 Indications...... 4 SelfDefinition referral...... 5 ...... 5 Equipment...... Qualifications and Responsibilities...... of Personnel The Screening Mammography Report...... 68 SpecificationsQuality Control of...... the Examination ...... 79 Quality Assurance...... 9 1.2. Diagnostic Mammography and Problem Solving Breast Evaluation...... 10 ...... 10 Goal...... 10 IndicationsDefinition ...... 10 ...... 10 Equipment...... 10 Qualifications and Responsibilities...... of Personnel 11 The Diagnostic Report...... 11 DoubleSpecifications Reading of and the ComputerExamination Assisted Detection (CAD)...... 11 1.3 Tomosynthesis...... 11 2. Breast Ultrasound...... 13 Indications...... 13 ...... 13 ...... 14 DocumentationQualifications and...... Responsibilities of Personnel ...... 14 Specifications of the Examination...... 15 Quality Improvement Programs...... 15 2.1. EquipmentElastography Specifications...... 15 2.2. Automated Whole Breast Ultrasound (AWBUS)...... 16 3. Breast MRI...... 16 General Principles...... Indications/Contraindications...... 16 Documentation...... 1816 Qualifications and Responsibilities...... of Personnel 1718 Quality Control Program...... 19 EquipmentProtocols...... Specifications ...... 20 High-spatial Resolution Sequences...... 20 Basic Requirements for Breast MRI...... 20 Quality Assurance...... 21 3.1. Diffusion Weighted Imaging...... 21 3.2. Spectroscopy...... 22 4. Alternative Imaging Methods...... 22 4.1. Thermography...... 22

1 5. Emerging Technologies...... 22

Section B: Breast Intervention...... 23 1. General Principles...... 23 2. Biopsies ...... 23 2.1. Selection of Image Guidance Modality...... 23 Mammographic Guidance...... 23 Stereotactic Guidance...... 23 Ultrasound Guidance...... 23 MRI Guidance...... 23 2.2. Performance of Breast Biopsy...... 24 Stereotactic and Ultrasound Guided Biopsies...... 24 I. Indications/Contraindications for Biopsy Under Stereotactic and Ultrasound Guidance...... 24 II. Biopsy Needle Selection...... 24 MRI Guided Biopsy...... 2.3. Nipple Discharge Investigation and Intervention...... 27 2.4. Complications of Breast Intervention...... 2627 2.5. Submission of Pathology Specimen(s)...... 27 2.6. Radiologic-pathologic Correlation...... 28 2.7. Qualifications and Responsibilities of Personnel Involved in Breast Biopsy...... 28 ...... 28 2.8. Documentation...... 29 2.9. EquipmentSpecifications Specifications of the Examination...... 30 2.10 Quality Control and Improvement, Safety, Infection Control, and Patient Education Concerns...... 30

3. Non-biopsy Intervention...... 31 3.1. Perioperative Localization and Imaging...... 31 Hook Wire...... 31 Surgical Specimen Imaging...... 31 Radioactive Seed Localization...... 31 Biopsy Markers...... 32 3.2. Abscess Drainage and Cyst Aspiration...... 32 3.3. Image-guided Breast Therapy...... 33 High Intensity Focused Ultrasound...... 33 Laser Interstitial Therapy...... 33 Radiofrequency Ablation...... 33 Cryosurgery...... 33 3.4. Qualifications and Responsibilities of Personnel for Breast Intervention...... 33 3.5. Specifications of the Examination...... 34 3.6. Documentation...... 34 3.7. Equipment Specifications...... 34 3.8. Quality Control and Improvement, Safety, Infection Control, and Patient Education Concerns...... 35

Appendix A – BI-RADS® and Other Reporting and Data Resources...... 36

Relevant Links...... 37

2 PREAMBLE

In this document the breast imaging committee intends to present what is considered best breast imaging practice at the time of development. The committee encourages best clinical practice and with the aid of these practice guidelines and consensus statements, hopes to provide radiologists as well as technologists, and other allied staff with a consensus-based approach to include clinical indications and technical standards for performing and interpreting breast imaging, as well as performing breast interventional procedures.

These guidelines are in accordance with those pub- lished by the Canadian and American Cancer Societies, the National Comprehensive Cancer Network and the American College of Radiology. Their purpose is to serve as an educational tool and provide minimum requirements to the practitioner; however, they are actions differing from those recommended may be appropriatenot intended depending to be inflexible. upon Itresources is acknowledged available that to the radiologist, patient factors, changes in technology and knowledge evolving after the publication of these forguidelines. a particular Ultimately, patient the is the final responsibility judgment regarding of the supervisingappropriateness radiologist of a given with examination aid from the or intervention medical physicist and technologist.

This version of the Guideline incorporates what were previously the Standards for Breast Imaging, Breast Ultrasound and Breast Interventional. New in this version are Breast MRI and brief discussions of several technologies and therapies which are new since the last Standards. The current Guideline is divided into Breast Imaging and Breast Intervention.

As this version will likely be viewed electronically more than prior versions, we have included several links in a section at the end and also scattered within the document.

3 SECTION A: BREAST IMAGING 1. MAMMOGRAPHY INDICATIONS a) Asymptomatic women 40–49 years should 6 1 undergo screening mammography every year I.1. SCREENING MAMMOGRAPHY 7 Mammography is a proven technique for detecting screening mammography every one to two years8 malignant disease of the breasts, particularly at an b) Asymptomatic women aged 50 to 74 should undergo early stage. In the presence of breast symptoms, mammography at one to two-year intervals if they mammography is used not only to further evaluate c) areWomen in good over general the age health of 74 should have screening the breast, but in some cases may be used to allow 5 and common practice indicate that, other unsuspected neoplasms. while screening mammography is not routinely recom- for a definitive conclusion, as well as detection of mendedOther guidelines for women under age 40, it may have a role for It should be noted that the indications listed below for selected individuals in the high risk category. Where screening are CAR guidelines. It is acknowledged that - pre-menopausal breast cancer, referral for mammogra- there is a family history of a first degree relative with ofthere the areCAR. other jurisdictional and international guide lines and practices in existence that differ from those than the age of the relative’s diagnosis. While there is periodic controversy2 around the value phy may be advised at an age five to ten years younger MRI is indicated for certain high-risk populations of mammography, appropriate screening age groups and screening intervals, population-based trials have shown that periodic screening of asymptomatic women being(see, MRI developed, INDICATIONS/CONTRAINDICATIONS some of which employ ultrasound below). reduces mortality from breast cancer3. As is true for Other personalized high-risk screening9. protocols are

required at all levels. Important considerations include asRisk an factors adjunct for to breast mammography cancer include previous biopsy credentialingother radiological and criteria examinations, for professionals, optimum qualityequipment is showing cancer or high-risk lesions, strong positive

image quality standards, imaging evaluation standard- radiation, underlying genetic abnormalities, breast specifications,ization, meticulous monitoring record andkeeping, maintenance and periodic schedules, review family history, previous exposure to high doses of chest and analysis of outcome data. inactivity,tissue density, smoking, early moderate menarche, alcohol late childbearing: consumption DEFINITION delivery of first child at age over 30 years, obesity and (estrogen-like e.g. BPA, phthalates). Measures of risk women to detect abnormalities which can lead to a (2 drinks per day), and chemical/hormone exposure diagnosisScreening of involves early stage the examinationbreast cancer. of Small asymptomatic tumour size to develop cancer in a given future interval per year, are best defined as a percentage of women expected surgical treatment, reduced need for chemotherapy and given future age, as lifetime risk. A number of mathe- areand associated negative lymph with increasednode status survival necessitate4. When less an extensive abnor- maticalin the next models given are number available of years, to calculate from current a woman’s age to lifetime risk for developing breast cancer, such as Gail, woman is referred for additional study; therefore the - mality is identified by the screening mammogram, the http://www.ems-trials.org/riskevaluator) radiologist in attendance. Despite its sensitivity, however, Claus, BRCAPRO, IBIS (IBIS Breast Cancer Risk evalua mammographyscreening examination does not can detect be performed all breast cancers;without a thetor tool:most comprehensive in the assessment of family historyand BOADICEA. of both breast The latter and ovarianthree are carcinoma considered10. to be complementary procedures, together with breast self- ® therefore, mammography and clinical5. For examination certain high-risk are The National Comprehensive Cancer Network (NCCN) populations, MRI is also an appropriate screening has more information on personalized high risk examinationmodality. Please or breast refer awarenessto MRI section for further details. screening. This is available at www.nccn.org.

4 SELF REFERRAL Physicians and Surgeons of Canada. of Certification Program of the Royal College of rangeIn some wishes jurisdictions to pursue self screening referrals outside are permitted. an organized In Radiologists interpreting mammography should adhere screeningthese jurisdictions, program, if she a woman is encouraged within the to screeningprovide the age to the CAR Mammography Accreditation Program name of the primary health care professional to whom (MAP) requirements. For further information, please the report will be sent. If the woman is unable to provide contact the CAR MAP directly (http://www.car.ca/ the name of a primary health care professional, a name en/contact.aspx). should be chosen from a pool of willing health care providers. This pool should be maintained to take Medical Radiation Technologist referrals from screening mammography. Medical radiation technologists (MRTs) performing mammography must have Canadian Association of screening result. The woman should also be directly notified of her Medical Radiation Technologist (CAMRT) Certification If the mammogram report is abnormal, both the woman orUnder be certified the overall by an supervision equivalent recognizedof the radiologist, licensing the body. MRT will have the responsibility for patient comfort A standardized radiology screening results report must and the selected health care provider should be notified. image technical evaluation and quality, and applicable be issued for both normal and abnormal results, in a qualityand safety, assurance. examination The MRT preparation should receive and performance, continuous supervision on image quality from the interpreting timely fashion. This report must document specific radiologists. Technologist QA programs, including findings and follow up recommendations. systematic review, should be encouraged. mammography results in a timely fashion. The woman must receive written notification of her The training of MRTs engaged in specialty activities shall meet with the applicable provincial and national QUALIFICATIONS AND RESPONSIBILITIES OF PERSONNEL mammography either in his or her training curriculum The personnel standards for education and conduct orspecialty through qualifications. special courses, The and MRT must shall perform have training mammog in - are determined by the unique demands of mammogra- raphy on a regular basis. Where using or converting phy practice. to digital mammography, training with an application

Radiologist is recommended, with attention paid to the artifacts, Radiologists involved in the performance, supervision displayspecialist and or software other trained concerns or experienced unique to digital personnel imaging. and interpretation of mammography must have a Continued professional development in breast imaging is encouraged by the CAMRT and should meet perti- the Royal College of Physicians and Surgeons of Canada nent provincial and CAR MAP requirements. and/orFellowship the Collègeor Certification des médecins in Diagnostic du Québec. Radiology Equivalent with

Medical Physicist bodyforeign and radiologist holds a valid qualifications provincial arelicense. also acceptable if A medical physicist must take the responsibility for the radiologist is certified by a recognized certifying the initial acceptance testing, and for conducting and As new imaging modalities and interventional tech- overseeing quality control testing of the mammographic niques are developed, additional clinical training, under unit and viewing chain for digital imaging. supervision and with proper documentation, should be obtained before radiologists interpret or perform such The medical physicist shall have a graduate degree and be - tional training must meet the pertinent provincial/ (CCPM) in the specialty of Mammography, or its equiva- certified by the Canadian College of Physicists in Medicine regionalexaminations regulations. or procedures Continuing independently. professional This develop addi- lent, or any relevant provincial/territorial license. Please ment must meet the requirements of the Maintenance visit www.ccpm.ca for further information.

5 compression device and a removable grid. While physics of mammography, systems components and performance,Training and experience safety procedures, shall include acceptance knowledge testing, of the digital mammography technologies11, 12, 13, digital quality control and CAR Mammography Accreditation there is some evidence of variance between specific Program (MAP) requirements. 14 , including decoupling of mammographyimage acquisition overall and storage. has significant For this benefits reason, overdigital screen-filmequipment ismammography recommended when purchasing a responsibilities, please refer to the individual modality mammography unit15. All mammography units must be For more specific information about medical physicist sections within this document. licensed by Health Canada (HC) as class 3 (appropriate

Information Systems Specialist on mammography equipment please refer to the Health An Information Systems Specialist (ISS) is required by Canadafor mammography) Canadian Mammography upon installation. Quality For moreGuidelines specifics facilities performing digital imaging. This individual website (http://www.hc-sc.gc.ca/ewh-semt/pubs/ must be either on site or available upon request. He/ radiation/02hecs-sesc267/index-eng.php). Additionally, a searchable list of all actively licensed maintenance and quality control of information technol- medical devices is available at www.mdall.ca. she must be trained and experienced in installation, of this individual will depend highly on the type of The mammography unit must be evaluated at the facilityogy software and the and type hardware. of equipment. The required qualifications time of equipment installation and before any patients -

required by federal/provincial/territorial regulations medicalare scheduled physicist. for mammography All corrective actions exams. requiredThe perfor on The ISS should possess any relevant qualifications non-compliantmance must be verifiedtests must by abe qualified addressed mammographic before any recognized standard such as that of the Society of Imaging mammograms are performed. The unit must then Informaticsand statutes, in and Medicine should or be the certified PACS Administratorsaccording to a be checked at least annually or more frequently if required by provincial legislation. The physicist report must be approved and signed by a medical physicist Registry and Certification Association. Training and expertise should include computer and of Physicists in Medicine (CCPM) or its equivalent certified in mammography by the Canadian College terminology,database basics, positioning networking and conceptsviewing characteristics,(such as DICOM, imagingHL7, RIS characteristics and HIS), security of various systems, modalities medical for imaging image service(see QUALIFICATIONS reports should beAND kept RESPONSIBLITIES for a minimum of OF three acquisition, transmission and storage, and facility work- (3)PERSONNEL, years. A procedure above). Copies manual, of maintenanceas well as a properly and/or documented log of the tests performed as part of the provincial, territorial and institutional privacy legislation quality control (QC) program, must be maintained. andflow. policies, The ISS suchshould as alsothe Personal be knowledgeable Information about Protection federal, and Electronic Documents Act (PIPEDA) For digital mammography, a review workstation compliant with the standards of Integrating the Healthcare Enterprise (IHE) is necessary. Two (2) patient record, understanding policies and procedures inResponsibilities place within the include facility, ensuring understanding confidentiality the impor of- required. Information on IHE can be obtained at tance and the requirements for an information systems www.ihe.net5‐megapixel monitors,. and appropriate software are quality assurance program, and communicating any changes/upgrades to staff, as well as resulting conse- Compression devices should be designed to improve quences for facility operations. contrast, minimize radiographic scatter, ensure uniform

EQUIPMENT density, and reduce dose and subject motion. Molybdenum Specifications mammographytarget tubes with systems molybdenum may use or various rhodium anode filtration target The mammogram must be performed only on dedi- are appropriate for film screen mammography. Digital cated mammography equipment with an adequate aluminum or silver. materials, including filters of molybdenum, rhodium,

6 Conventional Film Labelling should be 0.3 mm for contact mammography, and Adequate documentation of the study is essential. For mammography, the focal spot size of the x-ray tube All radiographic images should be labelled in accor- receptor distance for contact mammography should be dance with the current recommendations of the CAR 500.1mm cm or for more. magnification mammography. The focus to Mammography Accreditation Program. Film labelling

- shoulda) Facility include Name an identification label containing: A dedicated film processor with developer time and b) Acquisition Date temperature designed specifically for the single emul c) Acquisition Time designedsion film being for 90 used seconds for film/screen processing mammography is acceptable. is d) Facility Address Therecommended. CR reader and As an laser alternative, printer require mammography appropriate film e) Station Name parameters and QC. g) Patient’s First and Last Names Please contact the CAR MAP (http://www.car.ca/en/ h)f) PatientOperator ID Initials and/or (or Date ID ofnumber) Birth contact.aspx) for a list of required QC testing. i) Cassette (screen) number

Radiation dose roman numerals The average glandular dose for the standard breast j) Mammography unit identification using must be determined at least annually. The average - - tion. The standard breast is represented by a 4.0 cm tionThe filmof laterality should also and include view. This a standardized marker must radiopaque not thickglandular PMMA dose phantom cannot whichexceed attenuates 3 mGy for similarlya CC projec to obscuremarker placed image oninformation. the film near the axilla for identifica a 4.5 cm thick compressed breast consisting of 50% glandular and 50% adipose tissue . Digital Image Labelling 16 Adequate documentation of the study is essential. It is Radiation protection important to ensure certain key information is auto- Aprons and collars are not routinely required (see CAR matically transferred from the digital mammography

http://car.ca/en/standards-guidelines/ car_position_papers.aspxPOSITION STATEMENT ON) THEas radiation USE OF protectionTHYROID for image acquisition system to the stored DICOM image. SHIELDS: listed in the chart below, ideally without additional mammography, as the amount of scattered radiation is Systems must provide all of the information fields negligible. At the time of writing, it is recommended that radiation protection be used for patients who are manual entry by the operator. The DICOM header pregnant or who fall outside of the 10 day rule, but shoulda) Facility contain Name the following tags: require urgent mammographic assessment. b) Acquisition Date c) Acquisition Time SPECIFICATIONS OF THE EXAMINATION d) Facility Address e) Station Name

The examination should ordinarily be limited to a g) Patient’s First and Last Names requiredcraniocaudal to visualize and mediolateral breast tissue oblique adequately. projections When of an h)f) PatientOperator ID Initials and/or (or Date ID ofnumber) Birth each breast. Occasionally, additional projections may be i) kV the woman is referred for additional imaging studies and/orabnormality biopsy. exists which must be investigated further, k) Anode Target Material l)j) FilterExposure Material Time and X‐ray Tube Current (mAs) Comparison with previous images m) View Position obtained when practical. o) Image Laterality Original images of previous studies should be n) Patient Orientation

p) Numerical mammography unit identification

7 View boxes and monitors Digital Image Retention

This is generally higher than that required for viewing retained by the facility and made available to the patient conventionalView boxes should radiographs. provide This a high should luminance be evaluated level. by Original mammogram data (“for processing”) should be the medical physicist annually. It is essential to mask the must be retained for a statutory period which must be consistentfor a minimum with periodclinical of needs five (5) and years. relevant Mammograms legal and local health care facility requirements. densitiesarea around that the can mammograms be seen without to “bright-lighting”exclude extraneous each light which reduces image contrast and limits maximum At this time, as part of the CAR MAP guidelines, digital should be available. mammography images must have absolutely no lossy film. Magnification lenses and bright-light capabilities compression. Images sent to other facilities should be sent on media or electronically with non-proprietary that they are in optimal condition. lossless compression so that they can be displayed on All view boxes should be checked periodically to assure the consulting physician’s IHE compliant workstation In the case of digital mammography, the MRT will use a monitor to ensure that the images are of diagnostic Free standing and mobile settings quality prior to image interpretation by a radiologist. Screening mammography may be performed in non- traditional settings where a radiologist may not be in display and interpretation by the radiologist. The attendance. This includes digital telemammography. monitorsTwo (2) 5-megapixel must be checked monitors annually are required by the for medical image described standards and guidelines cited here as monitor must be available solely for technologists, at all documentedThe examination protocols. offered must follow all of the times.physicist This (see can EQUIPMENT, include the acquisition above). One station. (1) 3-megapixel The MRT should work under the same rules whether in Viewing conditions

aWhere fixed practical,or mobile the setting. radiologist supervising the facility, or shouldContrast be is positioned extremely toimportant avoid light in thefrom mammographic windows, other image and is degraded by extraneous light. View boxes for consultation and should visit the facility at least monthlyan appropriately to observe qualified the performance delegate, should of mammograms be available levelview andboxes, diffuse. and otherDigital sources monitors of shouldbright belight, maintained either and assure that safe operating procedures are followed. direct or reflected. General lighting should be at a low at adequate luminance, according to manufacturer Quality control documentation should be reviewed by

When interpreting digital screening mammograms delegate, and a log of these visits must be maintained. specifications. the supervising radiologist, or appropriately qualified in a screening setting and utilizing analog screening THE SCREENING MAMMOGRAPHY REPORT Most screening mammograms are normal. A small mammograms films for comparison purposes, the percentage will be reported as abnormal and recom- viewbox (for the analog films) should be in close mendations will be made for further diagnostic workup. Conventionalproximity to the digital Film (reading)Retention monitors. Reporting should be according to the CAR Standard for Communication of Diagnostic Imaging Findings, available and made available to the patient for a minimum period at www.car.ca. As well, use of the American College of Original mammograms should be retained by the facility Radiology (ACR) document Breast Imaging Reporting ® statutory period which must be consistent with clinical Data Systems (BI-RADS ) is encouraged. This is available needsof five and(5) years.relevant Mammograms legal and local must health be retained care facility for a requirements. available online at www.acr.org. A description of abnormalitieson request from detected the ACR at officescreening and excerptedand recommenda text is - tions for diagnostic work up should be included in the report. For abnormalities which are highly suggestive

8 of malignancy, the report should be directly communi- cated to the referring health care professional in a for mammography use) should undergo regular manner that ensures receipt and documentation of the preventiveThe CR readers maintenance and laser as printers stipulated (with by specifications the manufac- turer, and the QC activity must be carefully recorded Where appropriate, further investigations, such as (please refer to the CAR MAP requirements). reports, such as by telephone, fax or registered mail. Monitor calibration is assisted by ISS personnel and medical physicist annual review. Viewing conditions QUALITYbiopsy, may beCONTROL expedited by the reporting radiologist. are assessed solely by a medical physicist during their A documented quality control program with procedure annual review. manuals and logs should be maintained in accordance with the CAR Mammography Accreditation Program’s Practice Guideline for Determinants of Image Quality in Digital Mammography is available online at MAP coordinator in order to receive a copy of the www.acr.org. Qualityquality controlControl specifications.Checklists. Please contact a CAR QUALITY ASSURANCE Radiologist The radiologist will be responsible for ensuring that Outcome data medical radiation technologists have adequate training Systems for reviewing outcome data from mammogra- and maintenance of competence. He/she or a designate phy should be established. To enable an assessment of must ensure that the MRTs and medical physicists the true and false positive rates, the minimum data to be perform the appropriate tests on schedule, and that all collected include date range of audit, total number of ® records are properly maintained and that the quality of 0, 4 and 5 cases ® clinical images is acceptable. Set up and maintenance and biopsy results of all BI-RADS 4 and 5 cases. Data to exams performed, number of BI-RADS of digital viewing equipment may require consultation be collected should include tumour size, nodal status, with an Information Systems Specialist. histologic type, and grade. Screening data should be distinguished from diagnostic data. Where possible, records of false negative mammograms should be Technologist collected and the cases analyzed. Cross references with The medical radiation technologist will be responsible the provincial cancer registry should be performed for routine tests including darkroom cleanliness, if possible. processing quality control, screen/digital reader - Performance should be correlated against established tions, phantom images, artifact testing, visual checklist, benchmarks15. Please refer to the Public Health cleanliness, view boxes/monitors and viewing condi Agency of Canada Performance Measures. repeat analysis, analysis of fixer retention in film, Comparison with previous mammograms Medicaldarkroom fog,Physicist screen film contact and compression. The medical physicist will be responsible for the mam- available for consultation and second opinion where mographic unit evaluation, collimation assessment, practical.Original images Where from prior previous images are studies digitized, should the be original made focal spot size and/or resolution measurements, beam images should be available for review upon request. quality assessment (half value layer measurements), Digitized images must be of high quality and must not be used for diagnosis. assessment, uniformity of screen speed entrance automatic exposure control system performance evaluation. exposure, average glandular dose and artifact Phantom evaluation of image quality, artifact assess- ment and appropriate tests should be performed on an annual basis.

9 1.2. DIAGNOSTIC MAMMOGRAPHY AND PROBLEM SOLVING BREAST would be candidates for screening mammography reflect pathology, and women with such symptoms 14 b) Women with abnormal screening mammograms EVALUATION c) Follow-up of women with previous breast cancer In contrast to screening mammography, diagnostic d) Short interval follow-up (less than one year for mammography is intended to evaluate patients with clinical or radiologic concern) clinically detected or screening detected abnormalities. e) Suspected complications of breast implants f) Any circumstance in which direct involvement of DEFINITION - This is a comprehensive imaging evaluation of a patient with a breast mass, nipple discharge, pain, dimpling, an theconsultation radiologist is required, for example, monitor abnormal or questionable screening mammogram, or ing sonography, physical examination and/or Special Circumstances reconstructed breasts will be included for diagnostic a) Pregnancy and Lactation: Elective mammogra- evaluationother physical if they finding. are not Women eligible with for a augmentedscreening pro or- phy should not be performed during pregnancy gram. The mammogram should be correlated with the or during lactation because of increased sensitivity to radiation damage in the proliferating breast. knownIf a woman physical presents findings for screening and/or symptoms. mammography and Diagnostic investigation starts with targeted reports a clinical problem, the patient may be converted ultrasound. However, mammography should be performed if malignancy is suspected. As gadolinium contrast is not recommended for toThe diagnostic diagnostic and (workup) should have mammogram her report expedited.is planned use in pregnancy, enhanced MRI should not be and tailored for the needs of the individual patient. performed in pregnancy unless assessment with It should be done under the direct supervision of a MRI is critical to acute patient care and cannot be avoided. MRI can be performed for suspected malignancy during lactation. It is not necessary to The diagnostic mammogram may be performed along radiologist qualified in mammography. suspend breastfeeding after iodinated contrast or with additional studies, including but not limited to gadolinium administration . breast sonography, MRI, imaging guided needle biopsy b) Females under the age of 3017 with a palpable and/or galactography. undergo targeted ultrasound. Thereafter, GOAL abnormalitymammography or significantshould be performed symptoms ifshould there A diagnostic evaluation is performed to assess the is suspicion of malignancy18. patient with an abnormal screening mammogram or c) If a male presents with a breast lump suspicious for malignancy, mammography and/or breast should be given to time and cost. Protracted investiga- ultrasound is indicated. If the symptoms and tionsclinical should finding. be Duringavoided diagnostic wherever workup, possible consideration to allow a and follow-up may be all that are required19. history are typical of gynecomastia, clinical exam definitive diagnosis and avoid the anxiety of prolonged conclusion and/or additional recommendation for QUALIFICATIONS AND RESPONSIBILITIES management.follow-up. After interpretation, there should be a specific OF PERSONNEL The same criteria apply as for screening mammography INDICATIONS a) Any male or female with signs and symptoms suggestive of breast cancer, including, but not (see QUALIFICATIONS AND RESPONSIBILITIES OF limited to a palpable abnormality or thickening PERSONNEL, above). localized nodularity, dimpling or contour deformity, EQUIPMENT a persistent focal area of pain, and spontaneous serous or sanguineous nipple discharge from a apply as for screening mammography. However, for diagnosticThe same specificationsmammography, for current equipment standard and detectorits use

single duct. Other types of discharges may not 10 - DOUBLE READING AND COMPUTER sion capability with a small focal spot of 0.1mm for ASSISTED DETECTION (CAD)20 equipment must have magnification and spot compres Double reading of mammograms is performed using two separate individuals to interpret a single mammo- magnification imaging. SPECIFICATIONS OF THE EXAMINATION gram. It is shown to increase the sensitivity with a mild The nature and site of clinical or mammographic with arbitration. It is used in some settings, but is and acknowledged in the report. The location should be limiteddecrease by in cost specificity and manpower although limitations. this may be improved describedconcern should according be documented to various priorconventions, to the examination including the clock face position, breast quadrant, location within Computer-assisted detection or computer-aided the coronal plane and distance from the nipple. diagno- sis (CAD) is being developed in order to overcome some of the practical limitations of double Areas of clinical concern can be marked using radiopaque reading, but while it may result in a modest increase on the image, and to provide positioning guidance. compromised. devices to confirm that the area of interest was included in detected lesions, to date specificity is significantly Both double reading and CAD are proven to increase Additional projections, such as spot compression, spot- tionscompression may be selectedwith magnification, by the radiologist. tangential It is preferableprojections, to more than double reading. Double reading is encour- sensitivity, but CAD is shown to decrease specificity placeprojections the area with of concernmarkers closestand other to the specialized image receptor. projec aged where possible, but readers should be aware of the limitations of CAD at the time of writing. Both the MRT and supervising radiologist should be aware of any sites of clinical concern to ensure adequate 1.3 TOMOSYNTHESIS monitoring during the study. Digital Breast Tomosynthesis (DBT), often referred to as “three-dimensional” (3D) mammography, is a form Implant evaluation should include craniocaudal and of serial sectioning created by digital reconstruction of multiple mammographic images into overlapping displacement views. If displacement views cannot be - performedmediolateral due oblique to immobility projections, of the as implant, well as 90implant degree nesses, depending on the vendor and/or software used lateral images should be added to the standard views. forslices. display. The slices Images may are be obtained adjusted in to the variable same plane thick as Prior images should be obtained for comparison the original compression plane and are read as planar when possible. images. Synthetic views are two-dimensional (2D)

acquired during DBT data acquisition. previously cited for screening mammography. projection images reconstructed from the information Image labelling should conform to the specifications Studies comparing DBT with two-dimensional (2D) THE DIAGNOSTIC REPORT Digital Mammography (DM) for the investigation of All areas of clinical or radiologic concern should be patients recalled due to a questioned abnormality acknowledged in the report. The report should describe detected on routine mammography have consistently the pertinent observations, establish a level of suspicion the potential to decrease false-positive recalls by demonstrated a significantly improved specificity with recommendations for patient management. The report 30%–40% . DBT diminishes the effects of shouldbased upon also documentthe imaging any findings, other breast and provide imaging specific studies overlapping21, tissue22, 23, 24, by25, 26 displaying one thin section of or procedures which have been performed, and should tissue at a time, and has proven valuable for the detection and evaluation of focal asymmetries, archi- Screening recommendations may be included. tectural distortion and some apparent masses. DBT has correlate these results with the mammographic findings. been found to be equal to, or better than, coned The same criteria for reporting and communication compression views for investigating 2D mammograph- of screening mammography apply. However, ically detected abnormalities ACR BI-RADS® should be used for all diagnostic also improves triage for those27, patients 28, 29 who will not breast imaging. . The ability. Reader of DBT confidence to reliably 27 benefit from ultrasound 11 RECOMMENDATIONS: studies have demonstrated promising results that • Where synthetic views are used without the demonstrate calcifications is less clear; however, some addition of 2D imaging41, 42, it is mandatory to when compared with 2D DM30. review the tomosynthesis stack. Synthetic-views indicate at least equivalent detection of calcifications must not be used independently43. At the time of writing, the radiation dose for a single • Where DBT is employed, both screening and of a single conventional mammographic image, but diagnostic, it is essential that there is access to wellDBT withinprojection acceptable is similar dose to, limitsor slightly31, 32. higher than that advanced breast imaging, which may include tomosynthesis-guided biopsy, second look ultra- To date, several DBT systems are approved by Health sound and/or breast MRI. This is in order to aid Canada. biopsy of subtle lesions which may not be visible on standard 2D mammography44. CURRENT CLINICAL INDICATIONS: • • Keep in mind that at the time of writing, synthetic screening tool worldwide. Results of large prospec- views may underestimate the suspicious morphol- Screening:tive and retrospective DBT is currently screening being trials introduced have as a demonstrated improved cancer detection rates, - and decreased call back rates. To date, the 2 large mendedogy of some for anycalcifications, new or indeterminate thus liberal use of 2D prospective European screening trials comparing magnification43 spot. compression views is recom 2D-DM with DBT and 2D-DM have demonstrated Challengescalcifications to implementation of DBT at the cancer detection rates of 33-53%. A large random- time of writing include, but are not limited decreased recall rates of 15-17% and improved ized control trial is currently underway, intending to45: • Interpretation time is at least double that of comparing 2D-DM + DBT with 2D-DM alone. The to enroll 67 000 patients at over 30 sites (T-MIST) routine 2D DM . study is designed primarily to investigate if 46,47 2D-DM+DBT has an effect on the screening popula- • Protocols optimizing diagnostic accuracy, quality tion and whether it detects lethal cancers (advanced cancers or small cancers with aggres- been fully standardized. In particular, the CAR sive markers). Many secondary aims including Mammographyassurance, radiation Accreditation dose and Programworkflow (MAP) have nothas recall rates are being addressed . 33, 34, 35, 36, 37, 38 tomosynthesis at the time of writing. • not finalized an accreditation protocol specific to • DBT has large digital storage requirements over suggestsDiagnostic: that DBT when is useful working in diagnostic up 2D screening workup. and above2D DM. It is recommended that the Early experience among working group members tomosynthesis stack be stored in addition to the spot tomosynthesis39. When working up full view 2D DM and synthetic images for the required findings, full view tomosynthesis is superior to retention time. In the future, advances in data compression, storage costs, synthetic view image howevertomosynthesis spot tomo findings, may ultrasoundbe useful for may workup be the of quality as well as empiric evidence of safety of first choice, especially for mass-like findings; synthetic-view-only comparison may modify this subtle architectural distortion. recommendation. some full view tomo findings, particularly areas of • nd look ultrasound • Although screening outcome benchmarks are improved with the use of DBT, longitudinal out- MRI directed “second look”: 2 comes are as yet unknown. DBTplus DBTalone, found respectively) 75% MRI-detected40. additional findings (52% and 50% for ultrasound alone and

12 PERSONNEL REQUIREMENTS: 2. BREAST ULTRASOUND48 In addition to standard mammography requirements Breast Ultrasound is an established, effective, diagnostic - imaging technique which employs the use of high- (see QUALIFICATIONS AND RESPONSIBILITIES OF frequency ultrasound waves for imaging, Doppler trainingPERSONNEL, as per above), the ACR it isrequirement. recommended that radiolo assessment, and elastography. gists get an initial 8 hours of specific tomosynthesis Technologists and medical physicists should obtain INDICATIONS appropriate training as available.

CONTRAINDICATIONS: Appropriatea) Investigation indications of palpable for breast abnormalities, sonography skin include: Similar to mammography (see SPECIAL changes and new dimpling (female or male) CIRCUMSTANCES, above). No known contraindications b) Investigation of serous or sanguineous nipple particular to tomosynthesis.

c) Investigationdischarge (see of NIPPLE focal, persistent, DISCHARGE noncyclical INVESTIGATION breast painAND orINTERVENTION, tenderness below) d) Further evaluation of ambiguous or abnormal

e) Initial imaging technique for evaluation of clinical abnormalitiesmammographic in findings. women under 30 years and in lactating and pregnant women49 f) MRI-directed (second-look) ultrasound g) Evaluation of problems associated with breast implants h) Treatment planning for post-operative brachytherapy i) Screening for high risk patients who cannot or are unwilling to undergo MRI screening50

j) initialGuidance staging for intervention of ipsilateral breast lesions that are k) (orAssessment are likely and to be) biopsy malignant of axillary51 lymph nodes in l) Follow-up of probably benign sonographic lesions (BI-RADS® complicated cysts52. 3) such as probable fibroadenomas, and

Breast1. Screening sonography for the is NOTgeneral appropriate population for:53

QUALIFICATIONS2. Ongoing follow-up ANDof proven simple cysts RESPONSIBILITIES OF PERSONNEL Radiologist Credentials Criteria Radiologists involved in the performance, supervision and interpretation of breast ultrasound must have a

with the Royal College of Physicians and Surgeons of CanadaFellowship and/or or Certification the Collège des in Diagnostic médecins duRadiology Québec.

Equivalent foreign radiologist qualifications are also 13 visit the facility on a regular basis to provide on-site certifying body and holds a valid provincial license. review of ultrasound procedures and sonographer acceptable if the radiologist is certified by a recognized supervision. As new imaging modalities and interventional tech- niques are developed, additional clinical training, under SPECIFICATIONS OF THE EXAMINATION supervision and with proper documentation, should be obtained before radiologists interpret or perform Lesion Characterization and Technical Factors54 additional training must meet with pertinent provincial/ a) Breast ultrasound should be performed with as high regionalsuch examinations regulations. or Continuing procedures professional independently. develop Such- a resolution as is practical, allowing for the depth and echogenicity of the breast being imaged (see Program requirements of the Royal College of Physiciansment must andmeet Surgeons the Maintenance of Canada. of Certification and focal zone selections should be optimized to obtainEQUIPMENT high quality SPECIFICATIONS, images. It is below). acknowledged Gain settings that Sonographer Credentials Criteria mass characterization with sonography is highly Technologists performing breast sonography should dependent upon technical factors. Use of different be graduates of an accredited School of Sonography, modes and settings (tissue harmonic imaging, or have obtained certification from the American spatial and frequency compounding, colour and Registry of Diagnostic Medical Sonographers (ARDMS), power Doppler) is encouraged. the Canadian Association of Registered Diagnostic b) The patient should be positioned to minimize the Ultrasound Professionals (CARDUP), the Medical thickness of the portion of the breast being evalu- Technology Management Institute (MTMI), or the equivalent. Mammography technologists performing breast tissue dominates the screen and where the chestated. Imagewall is depth seen, itshould should be appear adjusted at theso that posterior the in breast ultrasound. They should also be members of margin of the image. theirbreast national sonography or provincial must have professional specific qualifications organization. c) The breast sonogram should be correlated with any Consistent with the requirements of ARDMS or CARDUP, prior breast imaging, including mammographic, continuing medical education and minimum volumes sonographic and MRI studies. should be mandatory. d) Any lesion or area of interest should be viewed and

Sonographers should perform breast ultrasounds regularly in order to maintain high level of quality. e) Atrecorded least one in twoset of perpendicular images of a lesion projections. should Onebe view is insufficient. - Supervision and Interpretation of sions of a mass should be recorded in at least two Ultrasound Examinations dimensions.obtained without calipers. The maximal dimen A radiologist must be available for consultation with f) Breast mass characterization should be based the sonographer on a case by case basis. Ideally the radiologist should be on site and available to partici- margin, lesion boundary, echo pattern, posterior acousticon the following features features: and surrounding size, shape, tissue. orientation, If a shear-wave elastography pattern is available, pateIt is recognized actively in howeverthe ultrasound that the examination. geographic realities it should be noted with the KPa relative to the in Canada do not permit the presence of an on-site lesion and its ratio with the surrounding tissue radiologist in all locations. Adequate documentation of

(see ELASTOGRAPHY, below). each examination is critical. A videotape or video-clip DOCUMENTATION communityrecord may thebe useful reports as must an adjunct be timely. to the Furthermore, static images the a retrievable and reviewable image storage format. In radiologistin difficult cases.must be Despite available the bygeographic telephone isolation for consulta of a- theImages case of of all interventional important findings procedures, should this be includesrecorded the on tion with the sonographer and the referring health care relationship of the needle to the lesion. Images should professional. Where practical, the radiologist should also include the skin and the chest wall.

14 - QUALITY IMPROVEMENT PROGRAMS Procedures should be systematically monitored and Image labelling should include a permanent identifica evaluated as part of the overall quality improvement tiona) Thelabel facility that contains: name and location program of the facility. Monitoring should include evaluation of the accuracy of interpretation as well as b) Examination date c) Patient’s first and last name theData appropriateness should be collected of the in examination.a manner which complies d) orientationIdentification of numbertransducer and/or (radial/antiradial, date of birth with the statutory and regulatory peer review proce- e) transverse/longitudinal/oblique),Anatomic location including: side quadrant,(left/right), clock notation, or labelled diagram of the breast and review data. distance from nipple. Depth (using alphabet) may dures in order to protect confidentiality of the peer also be used. If alphabet notation is to be used to 2.1. ELASTOGRAPHY55 describe lesion depth, it is recommended that the Elastography is a sonographic method of assessing referring clinicians are educated as to meaning of tissue stiffness, taking advantage of the increased the nomenclature. stiffness of most cancer tissue. This has proven useful f) Sonographer and/or radiologist initials or other particularly in BI-RADS® category 3 and 4A lesion assessment.in improving It specificity is also shown when to assessing have utility solid in targetingmasses, identifier areas of greatest suspicion within a lesion for the should be placed in the patient’s medical record. The radiologist’s report of the sonographic findings purpose of guiding biopsy. Retention of the breast sonographic images should be There are two main techniques, qualitative and consistent with the policies for retention of mammo- quantitative. Qualitative elastography results in grams, and in compliance with federal and provincial greater inter-observer variability. For this reason, regulations, local health care facility procedures, and quantitative elastography, using shear wave propaga- clinical need. tion, is considered superior at the time of writing. Reporting should be in accordance with CAR Standard Limitations of elastography include, but are not limited for Communication of Diagnostic Imaging Findings. As to, small invasive malignancies, DCIS, papillary lesions, well, the American College of Radiology (ACR) document and mucinous carcinoma. Additionally, at the time of Breast Imaging Reporting Data Systems (BI-RADS®) writing elastography has not yet been incorporated should be used and is available on request from the ACR into the fee structure. www.acr.org. A full version can be purchased from the ACR. When including elastography in the sonographic assess- office and online at ment of the breast the radiologist should include KPa EQUIPMENT SPECIFICATIONS relative to the lesion and its ratio with the surrounding Breast ultrasound should be performed with a high- tissue and the elastography pattern (i.e. homogeneous, resolution and real-time linear array scanner operating heterogeneous, oval shape, etc.) in his/her report. at a center frequency of at least 10 MHz with pulsed, colour and power Doppler. Equipment permitting Elastography should not replace grey scale ultrasound

In general, the highest frequency capable of adequate images, but may be a useful adjunct to breast ultrasound. penetrationelectronic adjustment to the depth of focal of interest zone(s) should is recommended. be used. For thick layer of gel may be helpful. evaluation of superficial lesions, a stand-off device or a

15 2.2. AUTOMATED WHOLE BREAST 3. BREAST MRI58 ULTRASOUND (AWBUS) Automated whole breast ultrasound (AWBUS) GENERAL PRINCIPLES allows for mechanized performance and recording Breast MRI has made many advances in clinical imaging of ultrasound scans of the whole breast for later in the past decade. While it was an imaging tool used review by the radiologist. Images can be reconstructed in 3 dimensions. Depending on the machine used, guidelines was introduced, it has become an essential either static images or dynamic cineloops of the componentchiefly to image of breast breast imaging. implants It when now theperforms last set a of vital CAR whole scan are obtained. role in the investigation of breast cancer, as well as in screening women at high risk for developing breast AWBUS has potential advantages over hand-held cancer. Whether it is used as a problem-solving tool, a breast US (HHUS), including standardized reproducible screening test, or for staging patients with breast cancer, it has the highest sensitivity for detecting breast cancer 3D and multiplanar reconstruction capability, reduced of any clinical breast imaging tool available. These dependenceexamination, on dynamic operator cineloop skill, decoupling of ultrasound of acquisi scanning,- guidelines include the current applications of breast MRI, as well as fundamental requirements for breast tool for breast screening . tion and review, and is being56 explored as a potential MRI imaging in clinical practice.

support widespread adoption of this technology. The real INDICATIONS/CONTRAINDICATIONS roleAt the of timeAWBUS of writing, in daily there practice is insufficient is not yet established. evidence to Indications Limitations include patients with limited cooperation, implant rupture or other complications cases, and concern about the nipple area and other a) Breast implants: to determine presence of silicone- artifacts.limited inclusion Furthermore, of the thereaxillary is notail fee and code axilla associated in some with this practice. b) Problemnot replace solving: the need in the for case a biopsy. of equivocal mam mographic clinical and/or US findings. It should Similar to HHUS, the ability to detect DCIS is also limited. for breast cancer, with estimated lifetime risk of Additionally, the cancer detection performance of c) greaterHigh risk than screening: 20–25%. to This screen includes women women at high who risk AWBUS may not be equivalent to HHUS . are BRCA 1 and 2 gene mutation carriers, women 57 who received chest irradiation for treatment of another malignancy such as lymphoma between the ages of 10–30 years of age, PTEN Li-Fraumeni syndrome, Cowden syndrome, or Bannayan-Riley- Ruvalcaba syndrome, or one of these syndromes in - tion is included in the Screening Mammography first-degree relatives. Information on risk calcula

toINDICATIONS chemotherapy. section. d) Neo-adjuvant chemotherapy: to assess response primary carcinoma in a patient presenting with e) Occult breast cancer: to determine the site of a lymphadenopathy or other site of bony or body metastasesmetastatic breast when mammogramscarcinoma such and as axillarybreast ultrasound are negative. Also for patients with suspicious bloody or serous nipple discharge and negative mammograms and breast ultrasound.

residual disease. f) Peri-operative evaluation: to assess for

16 sound and breast intervention, including MRI-guided in the affected breast and to screen for occult biopsy. If MRI-guided biopsy is not offered by the g) Pre-operative staging: to assess extent of disease facility, a relationship with a referral centre offering patients). Although the evidence for assessing MRI-guided biopsy would be required. The results contralateral malignancy (expected in 3–6% of additional tumours are found in the affected radiologic-pathologic correlation regardless of where extent of disease has shown that at least 16% of theof biopsies biopsy isinitiated performed. based They on MRI should findings also be require tracked changes long-term patient outcome. by the radiologist recommending the biopsy. breast, there is still insufficient evidence that it procedure such as biopsy or localization A breast MRI accreditation program is not currently h) Intervention: to guide an MRI interventional available in Canada. The ACR has established an accredi- tation program for quality assurance of a breast MRI Contraindications program that can serve as a guideline for a breast MRI For Contraindications and Safety Information, please refer to the MRI Safety section of the CAR Standard for Magnetic Resonance Imaging. practice.a) Establishment The criteria and evaluated maintenance in the byprogram the facility include: of an outcomes audit program to follow-up positive QUALIFICATIONS AND RESPONSIBILITIES interpretations and correlate histopathology with OF PERSONNEL b) Reporting that uses the BI-RADS® terminology and The Radiologist and Appropriately the imaging findings Qualified Medical Personnel c) Calculation of statistics for each radiologist and facility Radiologists involved in the performance, supervision final assessment codes and interpretation of magnetic resonance imaging must The responsibilities of the supervising and interpreting with the Royal College of Physicians and Surgeons of radiologista) Review include: and validation of the clinical indication for Canadahave a Fellowship and/or the or Collège Certification des médecins in Diagnostic du Québec. Radiology b) MRI protocol c) Usethe examinationand dose of contrast certifyingEquivalent body foreign and radiologistholds a valid qualifications provincial license. are also d) Ensuring a physician is available when contrast acceptable if the radiologist is certified by a recognized As new imaging modalities and interventional tech- is given niques are developed, additional clinical training, under e) Interpretation of the imaging, including review supervision and with proper documentation, should be of pertinent prior breast imaging studies and obtained before radiologists interpret or perform such clinicopathologic review. f) Provision of a report additional training must meet pertinent provincial/ regionalexaminations regulations. or procedures Continuing independently. professional developSuch - interpretation g) Quality assurance of the imaging examination and The CAR endorses the standard for breast MRI radiolo- Program requirements of the Royal College of gist qualification, as developed by the American Physiciansment must and meet Surgeons the Maintenance of Canada. of Certification

In order to ensure a safe MRI practice, the supervising College of Radiologists. These are as follows: radiologist should be familiar with the MRI safety paragraph AND literature including the ACR white paper for safe MRI • Appropriate qualifications as outlined in the first practice, and policies of appropriate contrast and sedation use. • Supervise/interpret/report ≥150 breast MRI examinations in last 36 months OR In addition, the interpreting radiologist should practice • Interpret/report ≥100 breast MRI examinations and possess knowledge of imaging and diagnosis of • 15 hours CME in MRI in the last 36 months in a supervised situation breast disease. Breast MRI should be practiced in a facility with the capacity for mammography, ultra-

17 Medical Physicists DOCUMENTATION An MRI medical physicist should perform initial Image labelling should include a permanent acceptance testing of the MRI system immediately following installation, and prior to any clinical scanning. The medical physicist is preferably someone on site, identification• The facility label name that and contains: location but they can also be contracted to perform the testing. The credentials of the medical physicist should include • Examination date • Patient’s first and last name MRI technology). Furthermore they should also be a college certification in MRI physics (or other related • Identification number and/or date of birth accredited by either the Canadian College of Physicists be placed in the patient’s medical record. The radiologist’s report of the MRI findings should engineering societies in Canada (i.e. P.Eng), and shall Retention of the breast MRI images should be consis- in Medicine (CCPM), or one of the affiliated professional tent with the policies for retention of mammograms, in compliance with federal and provincial regulations, physicshave specific of MRI, training system and components experience and in performance, MRI. Training local health care facility procedures, and clinical need. safetyand experience procedures, shall acceptance include detailed testing, knowledge and quality of the control testing. Acceptance testing may be done by a Reporting should be in accordance with the CAR team of medical physicists as long as at least one of Standard for Communication of Diagnostic Imaging the group members has the aforementioned credentials Findings and takes responsibility for signing the report. • All pertinent and should observations include: • Areas of clinical or radiologic concern Medical Radiation Technologists

by the Canadian Association of Medical Radiation • Level of suspicion based on imaging findings TechnologistsThe medical radiation (CAMRT) technologist in the discipline must ofbe magnetic certified • breastSpecific imaging recommendations studies or procedures for patient management resonance, or be registered with the provincial regula- • Documentation/correlationBI-RADS® with of pre-existing tory body and authorized to work in the discipline of magnetic resonance. classification a retrievable and reviewable image storage format. The technologist is primarily responsible for perform- Images ofshould all important also include findings the skinshould and be the recorded chest wall. on ing the MRI scans and maintaining the overall safety of patients, staff and equipment within the MR environ- EQUIPMENT SPECIFICATIONS ment. This includes careful screening and preparation shall meet all provincial and federal guidelines, protocols (if required) to produce high quality, diag- includingThe MR equipment Health Canada specifications guidelines. and Health performance Canada nosticof patients, scans, ensuring technical patient and quality comfort, evaluation adjustment of images of and relevant quality assurance. MR technologists are patient. It is recommended a system be purchased also responsible for the MRI room safety and ensuring thatapproval is either is required already prior approved to the or scanning in the process of the first of that no maintenance staff enters the room without being 510k approved. The guidelines include, but direct supervision. All personnel have to be screened and educated about MRI by the MR technologist. MR technologists, if adequately trained, could also perform are not limited to, specifications of maximum static - magnetic field strength maximum rate of change of responsible radiologist. Continued education of MR magnetic field gradients (dB/dt), maximum radiofre technologistsintravenous gadolinium is encouraged injections by the CAMRT, requested and byshould the quency (RF) power deposition (specific absorption meet pertinent provincial regulations. rate;It is recommended SAR), and maximum that purchase auditory and noise upgrade levels.

in consultation with the supervising MR radiologist andspecifications the MR technologist. be written by the medical physicist

18 QUALITY CONTROL PROGRAM Quality Control Tests The following quality control tests shall be performed to provide a series of tests and measurements which mayThe objectivebe performed of an MRon a quality regular control basis to(QC) determine program if is the MR system is performing in a reproducible and anda) measurementdocumented: of central frequency predictable manner. Protocols for routine system b) measurement of system signal-to-noise ratio on a performance testing are still evolving. Quality control standard head or body coil tests should be conducted under the supervision of c) table positioning d) geometric accuracy months by the supervising radiologist. A preventive e) high and low contrast resolution maintenancethe medical physicist, program with is recommended review at least as everya mean six to f) artifact analysis minimize unscheduled down time. Performance Evaluation Tests Following acceptance testing each MRI site will be The following quality control tests shall be reviewed required to maintain their level of scan quality through the performance and assessment of weekly quality assurance/quality control (QA/QC) testing where by the medical physicist annually, and after any major appropriate. Acquisition of the test data can be done upgrade• review or ofmajor daily change quality in control equipment: testing records by an MRI technologist who has been trained by the • measurement of image uniformity MRI medical physicist in the QA/QC acquisition proce- • measurement of spatial linearity dure. All MRI technologists should be trained to run • measurement of high contrast spatial resolution and assess basic QA/QC scans. Testing is best done on • measurement of slice thickness, locations and separations clinical scanning. It is highly recommended the site • assessment of image quality and image artifacts followa routine the schedule: American first College thing of in Radiology the morning (ACR) prior guide to - – eddy current compensation lines for this procedure. This requires an ACR phantom – system shim and an MRI medical physicist. In the absence of ACR All quality control testing shall be carried out in accreditation, other weekly QA/QC procedures can be

As with acceptance testing, an MRI medical physicist, accordancePreventive maintenance with specific shall procedures be scheduled, and methods. performed followed as recommended by the specific MRI vendor. in Medicine or one of the Canadian Professional regular basis. Service performed to correct system certified either through the Canadian College of Physicists and documented by a qualified service engineer on a records maintained at the MR site. aEngineering record of the societies, QA/QC and data. having specific training and deficiencies shall also be documented and service experience in MRI, is required to analyze and maintain A quality control program with written procedures and logs shall be maintained at the MR site. The ongoing quality control program assesses relative changes in system performance as determined by an MR technologist and medical physicist. It is highly recommended that a qualified MRI medical physicist year(see QUALIFICATIONSto assess QA/QC results AND RESPONSIBILITIES and provide recommen OF - dationsPERSONNEL, (if any). above) is consulted at least once per

19 PROTOCOLS BASIC REQUIREMENTS FOR BREAST MRI Breast MRI protocols should be used to provide a) A dedicated breast coil. There are several available information on high-spatial resolution morphology, coils on the market. functional information on perfusion and capillary b) Temporal resolution of 1–3 minutes or less, ideally

c) Dynamic imaging, acquiring a stack of images leakage,A dedicated and breast tissue coil T1 andis required T2 relaxation for all cases times. of breast temporally60–90 seconds at least per 3acquisition. times, 1 pre and at least

dynamic contrast enhanced sequences (DCES) MRI. Only implant assessments do not require the 2should post-bolus be no injectionlater than of 180 contrast. seconds The after first the post- intravenous injection of gadolinium chelates; all other of gadolinium. The standard dose of 0.1 mg/kg gadolin- indications for breast MRI currently need an IV injection contrast injection. The last set of images should ium is used, and is optimized with a power injector at a be no earlier than 6 to 8 minutes after the contrast The angiogenic activity of cancers constitutes the basis d) Spatial resolution that uses the largest imaging rate of 2–3 mls/sec, followed by a 10–20 ml saline flush. injection. for breast cancer detection with breast magnetic resonance imaging. matrix within the acquisition window. In-plane e) Allpixel DCES size requiresof 0.5 X 0.5 a T1-weighted to 1.0 X 1.0 mm gradient and through echo HIGH-SPATIAL RESOLUTION SEQUENCES (GRE)plane pixel sequence size of that 1–3 meets mm. the requirements of Breast MRI is the most sensitive imaging method adequate temporal resolution. This may be achieved currently available for demonstration of invasive with 2D multi-section or three-dimensional (3D), breast cancer. However, angiogenic activity is not the fast (turbo) or regular, spoiled or nonspoiled. only factor responsible for enhancement of the breast. Compared with 2D imaging, 3D imaging has the advantage of stronger T1 contrast, and uses a the breast, and increased hormonal activity, may also shorter repetition time than 2D, with a higher resultOther conditionsin enhancing such lesions. as inflammatory Similar to mammographic processes in signal-to-noise ratio, which allows for thinner principles, high spatial resolution images are required (higher spatial resolution) sections to be acquired. to best evaluate the borders of enhancing lesions, and f) All 3D (2D T1 and T2 requires a certain range of to determine the most likely diagnosis. Higher spatial TR to produce the appropriate DCES) should use the shortest possible repetition time and a large correlationresolution increases with the timingthe specificity of menstrual and sensitivity cycle. When of the MRI. The sensitivity of Breast MRI is maximized by usually 90 degrees for 2D and 25–50 degrees for feasible, Breast MRI should be performed between flip angle (larger with longer repetition times, spatial and temporal resolution. 3D-GRE). Parallel imaging has enabled maximal daysPatients 7–14 should of the undergo menstrual standard cycle. mammography g) Current bilateral dynamic protocols use the trans- prior to breast MRI, and the mammography study and verse, sagittal, or coronal planes, and may be report should be available for review at the time of interpretation of the MRI. The prior mammograms resolution. If isotropic imaging is used, images can bevendor-specific successfully reformatted to optimise specialin all planes and temporal for viewing. h) Bilateral breast imaging protocols are required should have been performed six months or less before for all women undergoing screening (women at the MRI examination. increased risk for breast cancer), and anyone undergoing staging for a known breast cancer. This allows assessment of the contralateral breast, and facilitates comparison to avoid diagnostic errors. There are very few indications where unilateral breast imaging is utilized. i) Fat suppression is ideally applied to the dynamic pulse sequences, but should not be used at the

expense of temporal or spatial resolution. Fat 20 suppression may be achieved by a number of means of correlation with mammographic, sono- methods. This is most commonly achieved through graphic and or MRI guided biopsies Each facility should active fat suppression or fat saturation, by elimi- also adhere to an established quality control program nating signal from fatty tissue, or by choosing for magnets and coils that includes scanning a phan- tom. Facilities must use the Breast Imaging Reporting and Data System (BI-RADS® selective water excitation. Active fat suppression codes, and for the terminology used for reporting and breastrequires imaging, a very givenhomogeneous the structure field of across the breasts. the tracking outcomes (available) atfor www.acr.org final assessment). entire FOV, which may be difficult to achieve with breast by which to “shim” the fat signal greatly 3.1. DIFFUSION WEIGHTED helpsManually improve choosing the fata specific saturation. region Some of fat of in the the IMAGING60 inhomogeneous fat suppression may also be Diffusion-weighted imaging (DWI) is a relatively new subtracted out. and promising technique which may be added to routine Breast MRI in order to potentially improve enhancement pattern, and by placing a region of j) Kinetic data is acquired by visual assessment of the which relies on the use of MR imaging to depict the diffusivityspecificity of waterthe MRI molecules examination. within DWI a lesion. is a modality It relies interest (ROI) over the enhancing area. No more minimize inaccurate averaging of the enhance- on the principle that water may diffuse more readily than 3–4 pixels should be included in the ROI, to in lesions with decreased cellularity or high water the best to evaluate. A kinetic curve is generated content (such as benign lesions) vs. those with ment. The edges or maximally enhancing areas are with dedicated software. It should be recognized increased cellularity or decreased water content that the window widths and levels may vary (such as carcinomas). DWI may therefore allow between sequences and that it is important for differentiation of benign from malignant lesions, accurate visual assessment that the early and although few clinical studies are yet available to delayed contrast enhanced images should be displayed with the same window width and level. k) GRE T2 with or without fat saturation for evalua- confirmTechnical this. requirements for performing DWI include proper breast positioning within the breast coil, and uniform shimming and fat suppression. It should be Additionaltion of fluid, Sequences cysts, edema in the breasts. performed before the administration of a contrast • GRE T1 without fat saturation- for evaluation of fat, agent to minimize the effect of the contrast material. lymph nodes, and architecture of the breast and to Spin-echo echoplanar DWI is the most popular clinical see clip placed after previous image guided biopsy technique for generating DW images. Two diffusion-sen- • May use the body coil to evaluate lymph nodes in sitizing gradients are “sandwiched” around a 180 degree radiofrequency (RF) refocusing pulse before echoplanar cervical and supraclavicular areas imaging data collection. The strength of these gradients the axillary and internal mammary nodal stations, sequences may be used to determine the integrity determines the strength of the diffusion weighting. The • ofAxial breast and implants sagittal STIR with water saturation valueis often of expressedthe diffusion in the of water b- value in tissueof the isscan, called which the

QUALITY ASSURANCE59 apparent diffusion coefficient (ADC) value, and is Each facility should establish and maintain a medical by the average area covered by a molecule per unit measured in square millimetres per second, and defined outcomes audit program to followup positive assess- tissue. It is taken as the measured signal intensities from ments and to correlate pathology results with the at least two b- values (e.g. 0 and 1000 s/mm2). Both include evaluation of the accuracy of interpretation, as DWI, with inherent advantages and disadvantages that 1.5 and 3.0 T field strength magnets may be used with interpreting radiologist’s findings. The audit should - are beyond the scope of these guidelines. The optimal ination. Each center performing breast MRI should be b-values have yet to be determined, and the b-value ablewell asto appropriateobtain the correlative clinical indications pathology for results the exam by - exerts great influence on signal intensity and determina tion of the ADC value. No specific thresholds for ADC 21 values have been set, but it is recognized that malignant tumours have lower ADC values than benign ones, with some overlap. Early evidence suggests that non-invasive tumours have higher ADC values than invasive tumours.

3.2.The clinical SPECTROSCOPY benefit of DWI still requires more study. MR Spectroscopy (MRS) has also been used as an

theadjunct principle to Contrast-enhanced that MRS can measure Breast theMRI, amount as a method of a metaboliteof improving called the specificity choline in ofsuspected Breast MRI. breast It relies lesions. on In most cases, elevated levels of choline are a strong indicator of malignancy. However, not all breast cancers demonstrate elevated choline levels, and MRS cannot

application for Breast MRS is to distinguish benign from malignantdetect small lesions lesions before (<1 cm). biopsy. The Anfirst overall and most sensitivity studied

several studies. A second and perhaps more promising applicationof 83% and specificityis the use ofof Breast85% have MRS been for predictingreported in response to cancer treatment. 1.5 T magnets have been used with MRS, but the higher signal-to-noise ratio of

higher field strength magnets (e.g. 3T) is helpful to maximizing the benefit of MRS. 4. ALTERNATIVE IMAGING METHODS

4.1. THERMOGRAPHY61 Breast Thermography is thermal imaging using an infrared camera to produce a map of the patterns of

Thermography is an unproven modality in breast cancerheat and detection. blood flow It is notnear an the alternative surface ofto mammographythe breast. and there is no evidence to support its clinical use.

5. EMERGING TECHNOLOGIES Emerging technologies carry some promise, but have not as yet been statistically proven effective in screening or diagnosis of breast disease, and should be considered

impedanceexperimental. studies, These CT include, laser mammography, but are not limited to: andDigital transillumination. Optical Breast Imaging (DOBI), electrical

22 SECTION B: BREAST INTERVENTION 1. GENERAL PRINCIPLES62 2. BIOPSIES

Breast interventional procedures may be diagnostic, 2.1. SELECTION OF IMAGE GUIDANCE therapeutic, or both. Diagnostic procedures include, but MODALITY needle aspiration (FNAB) biopsy, spring-loaded core The percutaneous intervention guidance modality needleare not biopsy limited (CNB) to pre-surgical and vacuum-assisted wire localization, breast biopsy fine should be the modality with which the salient lesion is (VAB). Diagnostic/therapeutic procedures include cyst best visualized. In some cases, the lesion is visualized aspiration and abscess drainage. There are also some equally by more than one modality. For these lesions, emerging image-guided therapeutic procedures which other deciding factors should be considered, including are detailed near the end of the guideline. accessibility/wait times, cost, patient comfort, opera-

Image guidance should be used for biopsy of both palpable and impalpable masses provided that the MAMMOGRAPHICtor preference and radiation GUIDANCE exposure. mass is visualized. Palpation guidance is only neces- The use of mammography images for intervention sary if the lesion is not seen by any imaging method. galactography (ductography) and pre-operative The shortest distance from the skin to the lesion localizationprocedures iswith now an reserved alpha numeric almost grid.exclusively to should be used when possible. Image guided percutaneous biopsy is superior to open STEREOTACTIC GUIDANCE surgical biopsy for several reasons, including increased Stereotactic guidance is a method of localizing a lesion accuracy, decreased cost and wait times, and decreased in 3 dimensions using 2 angled mammographic images surgical morbidity and cosmetic deformity . 63 In this guideline biopsy and non-biopsy procedures isand preferred computerized over grid-type calculation mammographic of the depth (or guidance Z-axis) are separated due to the need for discussion of points becauseusing parallax. it is more When accurate available, for thestereotactic calculation guidance of the Z position of a lesion, is faster, and requires less ultrasound-guided biopsies are discussed together radiation. Stereotactic guidance may be used for any specific to pathology and follow-up. Stereotactic and while MRI guided procedures are treated separately lesion which is mammographically visible. Stereotactic because of significant differences from the other guidance can be used for lesions which are visible on guidance modalities, including the indications and use of contrast. These separations are somewhat tables are acceptable for stereotactic guidance. one projection only. Both add-on units and prone arbitrary and some crossover exists. ULTRASOUND GUIDANCE Ultrasound guidance can be used when a lesion (usually a mass or lymph node) is visualized sonographically. Prior to the performance of any ultrasound-guided

sonographically. percutaneous procedure, the finding should be assessed MRI GUIDANCE MRI guided intervention is required when a lesion that looks suspicious on Breast MRI (BI-RADS® 4 or 5) does not have a sonographic correlate on MRI-directed US, or mammographic correlate. The incidence of malignancy of such lesions is in the order of 25–30% , similar to the 64

23 PPV of mammographic detected lesions. A suspicious Axillary Nodes lesion on MRI with no ultrasound or mammographic correlate requires tissue diagnosis. All centers providing guidance. It may be required as part of pre-operative Breast MRI service are required to provide MRI-guided stagingAxillary for node the biopsy patient is with performed a suspicious under lesion ultrasound or known biopsies, or to have an established referral pattern with breast cancer if nodes have suspicious features . These a center providing this service. 66

include,• Cortical but are thickening not limited and/or to: eccentric bulging 2.2. PERFORMANCE OF BREAST (>2.5 mm or more than half the width of the node) BIOPSY • Small, deformed or absent hilum STEREOTACTIC AND ULTRASOUND GUIDED BIOPSIES • Abnormal flow (hyperemia in 67hilum and central I. INDICATIONS/CONTRAINDICATIONS cortex and/or non-hilar flow) gauge (i.e. < 14 gauge) core or FNAB may be used (see FOR BIOPSY UNDER STEREOTACTIC AND The abnormal cortex should be targeted, and a smaller ULTRASOUND GUIDANCE Indications BIOPSY NEEDLE SELECTION, below). Caution is required due to the proximity of large nerves and Cysts vesselsNode biopsy in the may axilla. be performed at the time of core

imperceptible wall, acoustic enhancement, and Including complicated cysts, defined as having an low-level echoes Contraindicationsbiopsy of the index lesion. • If a lesion is proven cystic, intervention is not • Inability to visualize lesion (absolute) indicated unless patient is symptomatic, although patient preference or distress may also prompt (relative) • Significant allergy to local anesthetic agent aspiration The risks of reversing anticoagulation often outweigh • If an infection/abscess is suspected, the procedure the potential complications of local hemorrhage in may be both diagnostic and therapeutic anticoagulated patients. Discussion with the referring physician on a case by case basis is recommended if Masses reversal of anticoagulation is considered. For further guidance, please refer to the Society of Interventional Radiology document, Consensus Guidelines for Including complex cysts, defined as having a thick Periprocedural Management of Coagulation Status (perceptible) wall and/or thick (≥0.5 mm) septations, 50% cystic), or predominantly solid masses with and Hemostasis Risk in Percutaneous Image-guided intracystic or mixed cystic and solid masses (at least eccentric cystic foci . Interventions. (http://www.sirweb.org/clinical/ 65 cpg/Consensus_Guidelines_for_Periprocedural_ Management_of_Coagulation_Malloy.pdf) Image-guideda) BI-RADS® percutaneous4 and 5 lesions biopsy is indicated for: b) Targeted suspicious mammographic- or II. BIOPSY NEEDLE SELECTION ultrasound-detected lesions following MRI Biopsy needle selection is based on several c) BI-RADS® 3 lesions at patient request d) Repeat biopsy, as an alternative to open surgical biopsy (preferably with a larger gauge needle than factors,a) Accuracy including: of sampling: In general, the larger the original biopsy) the needle (and the contiguous sample size), the more likely that the preoperative diagnosis will be Multiple lesions may require multiple biopsies if accurate and that there will be a lower likelihood multifocal or multicentric malignancy is suspected. of false negative biopsy or upgrading to a higher degree of malignancy at surgery . A lower upgrade rate is desirable, as it decreases68 the

24 number of operations a patient may need to g) Imaging modality: MRI guided biopsy is almost b) Lesion type: Certain lesions may be preferentially used for ultrasound guided procedures. Stereotactic sampledachieve definitive with VAB treatment.in order to avoid underestima- biopsiesexclusively can VAB, be performed whereas allwith types spring-loaded of needle areand , and vacuum-assisted needles. 69 tion, for example complex cystic lesions Fine Needle Aspiration Biospy c) Easeclustered of use: calcifications. For some lesions, Conversely, the choice FNAB of is needle accepted for axillary node biopsy. Fine Needle Aspiration Biopsy (FNAB) is defined as using may be influenced by challenges in penetration of Indicationsa fine needle to obtain cells for cytology examination. gaugethe lesion. core For needle, example, or may very result scirrhous in bending or sclerotic of the lesions may be difficult to penetrate with a large suspected ipsilateral breast malignancy • Axillary node biopsy when staging a known70 or needle. In this scenario, existing options include: of a very suspicious mass in the setting of a dedi- todissection create a oftunnel tissues leading with anesthetics, to the lesion, firing or vacuum the core • Expeditingcated rapid the diagnosis investigation clinic orand remote surgical location referral assistedneedle in biopsythe projected as VAB path, may use ease of penetrationa manual trocar of

may be a last resort, but if using a needle smaller • Investigationprior to definitive of suspected large core multicentric/multifocal biopsy. FNAB should thandense 14 fibrous gauge, tissue. dialogue Using with a smaller the pathologist gauge needle is not be used to exclude malignancy. recommended and careful radiologic-pathologic correlation is required to determine if the sample bemalignancy performed when in collaboration the index lesion with has the undergone surgeon is adequate. If there is suspicion of undersampling anddefinitive with on-site biopsy, cytopathologist although this should support. preferably or radiologic-pathologic discordance, repeat biopsy • Diagnosis of a solid mass when spring-loaded core with a larger gauge needle is recommended (see or VAB is not feasible due to patient factors. d) Safety: In the case of lesions located very close Caveats RADIOLOGIC-PATHOLOGIC CORRELATION, below). • Unless there is strong, preferably on-site cytopa- initial biopsy may be performed with a small thologist support, 14 gauge spring-loaded core to vital structures, including axillary structures, or VAB should be performed instead of FNAB for may also be a last resort in order to avoid trauma togauge surrounding or non-advancing structures core and needle. FNAB A isfine widely needle • Cytology (FNAB) is not the preferred method of obtainingdiagnosis ofa pre-operativethe index lesion. diagnosis of breast vary with operator preference, but choice of a lesion . needleused for smaller axillary than lymph 14 gaugenode biopsy. increases This the may risk 71 of undersampling/upgrading if used for assess- • TumourFNAB is NOTbiomarker appropriate assessment for assessment cannot be of 14 GAUGE NEEDLE, below). calcificationsperformed with without FNAB a samples. focal solid mass lesion. e) Cost:ment Inof general,the index needle lesion cost (see increases SPRING-LOADED as needle Spring-loaded 14 Gauge Needle Biopsy of any breast lesion should be performed with caliber increases, with fine needles being least costly. However, this cost must be weighed against a core biopsy needle, either spring-loaded or vacuum expensive and vacuum assisted needles most the cost of increased frequency of repeat or two- assisted. When using an automated spring-loaded biopsy device, 14 gauge needle (or larger) is recommended . If lesions are undersampled or upgraded. there is suspicion of radiologic-pathologic discordance,72 stage surgery to achieve definitive treatment if f) Access: The availability of equipment and repeat biopsy with a larger needle is required (see

minimum of four (4) 14 gauge cores is recommended for expertise may vary in remote or rural locations. RADIOLOGIC-PATHOLOGIC CORRELATION, below). A

25 solid masses and a minimum of ten (10) 14 gauge cores 73 to minimize the will not persist risk of undersampling. If using a needle74 smaller than presence of the79 lesion. Approximately 10% of lesions 14is recommended gauge, the number for calcifications of cores may have to be further can be performed. If with not computerseen on MRI, software a six month assistance or increased to achieve an adequate sample and very careful follow-up is recommended for confirmation. Targeting radiologic-pathologic correlation and follow-up/audit are required. Maintaining a dialogue with the pathologist gridcalculation and referencing of the x, y, a andmarker z coordinates placed on thefrom grid the such helps to ensure quality diagnosis. images. x, y are determined from counting over on the- nate is determined based on the slice thickness used. Vacuum-assisted Needles as a vitamin E capsule, or other fiducial. The z coordi

to obtain a larger sample than either 14 gauge Imaging in the sagittal and axial planes with the Vacuum-assisted needles (14-7 gauge) are used thenco-axial required, sheath to and demonstrate imaging obturator adequate is samplingrequired toof larger contiguous sample size results in improved confirm accurate placement. Post biopsy imaging is abilityspring-loaded to make core an accurate or fine needles pre-operative can provide. diagnosis, A follow-up MRI after a concordant benign pathology resultthe lesion. is obtained, It is recommended as post-biopsy to perform changes a make 6 month it is surgery and thus decreasing the need for two-stage surgicalsignificantly procedures reducing. the upgrade rate at subsequent images at the time of biopsy. 75 difficult to confirm accurate sampling based on MR Vacuum assisted biopsy (VAB) is commonly used with When a marker is placed, post-procedure mammography should be performed in two orthogonal views to and is associated with decreased upgrading at surgery . document tissue marker position, and the report stereotactic guidance to sample clustered calcifications76 should state the position in relation to the biopsy site using VAB. MRI-guided biopsies are almost exclusively performed - (seeThe physician’sBIOPSY MARKERS report of later MRI-guided in document). breast ment following spring-loaded core biopsy when there VAB may also be used as a next step for further assess interventiona) Procedure should performed include: is discordant pathology or insufficient sampling. b) Designation of left or right breast MRI GUIDED BIOPSY c) Description and location of the lesion For MRI-guided biopsies, vacuum assistance is d) Approach used preferable as ample evidence has shown that the e) Type and amount of contrast material MRI-detected77 lesions are small, with a high incidence f) Type of local anesthesia of atypia, and have a higher underestimation rate than g) Skin incision, if made with stereotactic biopsies . 14 gauge spring-loaded core h) Gauge of needle and type of device (spring-loaded, 78 vacuum-assisted, etc.) i) Number of specimen cores or samples, if applicable ofbiopsy precision, often which yields is insufficient often challenging samples when for conductingdiagnosis and requires extreme precision in targeting. This degree MRI biopsies and when targeting a lesion, is dependent on its relative position to the overlying grid. j) Tissuelocalization marker clip placement, if performed, with specification of name and shape of metallic The breast is stabilized with light to moderate com- k) Complications and treatment, if any l) Post-procedure mammogram, if obtained, docu- has been shown to interfere with lesion enhancement. menting tissue marker placement and location of pression between grid plates. Excessive compression the marker with respect to the biopsied lesion the breast is adequately positioned so that the targeted For any lesion that is benign and concordant, a A pre-contrast image may be obtained to confirm that lesion lies within the area of accessibility. If necessary, to document stability. lesion is posterior to the area of accessibility). follow-up breast MRI is recommended in 6 months the patient can be repositioned (for example, if the

A post-contrast sequence is obtained to confirm

26 2.3. NIPPLE DISCHARGE 2.4. COMPLICATIONS OF BREAST INVESTIGATION AND INTERVENTION INTERVENTION80 • allergy to local anesthesthetic Nipple discharge is a common symptom, but investiga- tion depends on the characteristics of the secretion. • infection • hematomalidocaine toxicity (most common with VAB)

greenishLow risk orsecretion milky. Low is defined risk secretions as expressible are most only, likely • implanttrauma to perforation chest wall/pneumothorax thebilateral, result arisingof hyperprolactinemia, from multiple duct duct orifices, ectasia, and/orand • trauma to neurovascular structures in axilla - nicating cysts. Low risk secretion does not require 2.5.• milk SUBMISSION fistula (during lactation) OF PATHOLOGY fibrocystic change with or without identifiable commu imaging work-up. SPECIMEN(S) Submitting a specimen for histopathology is a request for a consultant opinion. For this opinion to be effec- dischargeHigh risk nipple may be discharge clear, serous, is defined serosanguineous, as spontaneous, or franklyunilateral bloody. and arising High risk from discharge a single isduct more orifice. likely This to the specimen are essential. Providing good clinical be caused by carcinoma or papillary lesions and tive, accurate identification and good preservation of necessitates further investigation. Fluid cytology may be performed, but is only useful when positive81. In details is vital as the histopathological findings are the case of single duct nipple discharge, incidence interpreted in the clinical context. of malignant or high-risk pathology is reported to The requisition should be properly filled out with the be as high as 15%. following• patient information: complete name, age, date of birth, and collection date Ultrasound is the initial investigation. If the cause for • clinical history nipple discharge is a suspected papillary lesion, biopsy • side and source of tissue should be performed. FNAB is strongly discouraged • number of needle core biopsies submitted

Specimen containers should be labelled completely Ultrasound may fail to show lesions that are not associ- (see BIOPSY NEEDLE SELECTION, above). with patient information, collection site, date and ated with abnormally ectatic ducts or lesions that lie too physician’s name. When multiple specimens are to be far peripherally. If ultrasound shows no cause, or a must be submitted in a separate container completely may be performed. Emerging evidence suggests that labelledexamined as and indicated diagnosed above individually, each specimen Breastnonspecific MRI iscause a useful such tool as duct in the ectasia, assessment galactography of suspi- cious nipple discharge82, and may be performed in As a general rule, specimens should be placed in buff- patients with negative mammograms and US, often removal from the patient. Increased cold ischemic time may be more widely accessible than galactography. willered interfere formalin withwithin the approximately assessment and ten stainingminutes ofof thetheir demonstrating unexpected pathology. Additionally, MRI tissues. The volume of formalin is ideally twenty times For papillary lesions that are palpable or symptomatic, that of the specimen, but for very large specimens this may be reduced to ten times the volume of the speci- is not recommended even when the pathology report men. Very small specimens should be placed in formalin indicatesthe use of that VAB the alone, papillary without lesion further has been surgical completely excision, almost immediately (within one or two minutes depend- ing on the size); otherwise marked drying artifacts will removed at the time of VAB (see RADIOLOGIC- occur. Larger specimens with a high fat content, which PATHOLOGIC CORRELATION, below). towels to allow formalin to reach the upper surface of thefloat, specimen. may be covered within a few layers of paper

27 The container obviously must be able to accommodate 2.7. QUALIFICATIONS AND the specimen plus many times its volume in formalin. RESPONSIBILITIES OF PERSONNEL container with ease. INVOLVED IN BREAST BIOPSY The specimens should fit through the opening of the Radiologist and Technologist 2.6. RADIOLOGIC-PATHOLOGIC Credentials Criteria CORRELATION83 Radiologist, technologist, sonographer, and MR technol- Following receipt of the pathology report, an addendum ogist credentials are discussed in the Breast Imaging to the biopsy report should be produced by the radiolo- section of this document.

shouldgist in charge include of the the radiologist’s biopsy or by opinionhis/her assignedon radiologic- proxy For MRI guided breast interventions there are specific pathologicwhen required concordance to expedite or results.discordance This addendumas well as a ofadditional 3 hours ofrequirements: CME in breast the MRI radiologist intervention must and be suggestion for the appropriate management follow-up, qualified to interpret Breast MRI, have a minimum such as the need for further imaging, imaging follow-up, Maintenance of certification requires performing repeat biopsy or surgical consultation. Discussion with experience in performing percutaneous breast biopsies. the pathologist is encouraged when determining from another radiologist, 3 hours of Breast MRI biopsy appropriate management. CME6 breast every MRIs 3 years,every 2and years, radiologic-pathologic alone or with supervision - correlation of all biopsies.

beFor considered concordant at lesions a year. with For alesions definitive with benign concordant diagno SPECIFICATIONS OF THE EXAMINATION sis (e.g. lymph node, fibroadenoma), follow-up should The decision to perform an interventional procedure should conform to the general principles noted above. benign diagnosis that is nonspecific (e.g., fibrocystic If ultrasound guidance is used, a complete planning follow-upchange, apocrine may be metaplasia,prudent in orderbenign/fibrous to decrease breast the - chancetissue) aof six-month missed diagnosis assessment84. as well as longer term ing the mass and, particularly if there is suspicion of ultrasound examination should be performed, includ is used, pre-procedure images should be obtained, should be recommended, preferably using a method ensuringmalignancy, that axillary the area regions. of concern If stereotactic is located guidance within In cases of insufficient sampling, repeat biopsy that achieves a larger sample size than that of the the region of the paddle fenestration. original biopsy.

well as alternative procedures should be discussed rate of underestimation/upgrading. These lesions withBenefits, the patient. limitations, Informed and risksconsent of theshould procedure be obtained as For some lesions, excision may be required due to a high and documented. ALH, and FEA) LCIS, papillary lesions, radial scar, mucinousinclude, but lesions, are not spindle limited cell to: lesions,atypia (including phyllodes ADH,tumour, The breast, the probe or stereotactic equipment, and - ogy, but suspicious of origin in DCIS and recurrent should be prepared in conformity with the principles residualmicrocalcifications malignancy not following associated radiotherapy. with a specific pathol ofthe cleanliness field in which to minimize the procedure the risk is of to infection. be performed

For ultrasound-guided biopsy, the skin entry site and pathology is encouraged based on clinical grounds region of needle sampling should be evaluated with andWhere multidisciplinary possible, correlation consultation. with final surgical colour Doppler before biopsy. Any sizeable artery should be avoided. Using a high-frequency transducer, continuous visualization of the needle is possible and desirable. The length of the needle, particularly the tip,

28 Imaging labelling should include immediately prior to and during deployment of a permanent identification containing: should be visible during the examination, particularly a) Facility name and location as parallel to the chest wall as possible. spring-loaded device. The needle axis should be kept For stereotactic biopsy, the operating radiologist must b) Examination date perform or supervise lesion targeting. Needle position e)c) RightPatient’s or Left first breast and last names should be imaged during targeting and sampling. f)d) MeasurementIdentification numberof lesion and/or in three date planes of birth Documentation of needle position during sampling g) Location of the lesion in the breast using diagram, should be retained as part of the medical record. clock, or other consistent notation h) Distance from the nipple If using ultrasound guidance, compression may be i) Image of the needle within the lesion (Two orthog- applied after each needle pass. Hemostasis should be achieved, using direct compression, after the procedure has been completed. Theonal radiologist’s projections may report be required of ultrasound- for small lesion) Post-procedure imaging should be performed. guided interventional procedures of the Mammographic images should be performed if breast should include: a) Procedure performed placement of a radiopaque marker. Calcifications b) Right or Left breast calcifications have been sampled or if there has been c) Gauge of biopsy needle d) Number of passes/cores should be confirmed on a specimen radiograph. If e) Type and amount of local anesthesia calcifications are not present85. on specimen radiography f) Location of the lesion in the breast using diagram- the risk of insufficient sampling is greater than if there matic, clock, or other consistent notation If there is a reason to suspect that the patient may be a is calcification retrieval g) Immediate complications and treatment, if any h) Specimen radiograph or sonogram and results, marker should be placed. Also, consider requesting if performed biomarkercandidate for assessment. neoadjuvant The chemotherapy, latter cannot be a radiopaque performed i) Clip placement, if performed with FNAB specimens.

sonography, if performed 2.8. DOCUMENTATION j) Post-procedure mammography and/or A permanent record of interventional procedures should Post-procedure patient follow-up be documented on a retrievable image storage format. should include: Images showing the biopsy needle within the lesion on at least one pass are required. If there is concern that required treatment, if any partial volume averaging has simulated traversing a • RecordIdentification of communications of delayed complications with the patient and and/or very small lesion, a transverse image with the needle referring health care professional within the lesion is recommended to document the • Radiologic-pathologic correlation report/ position of the biopsy needle within the lesion. For addendum including follow-up recommendations VAB an image of the lesion in the aperture of the needle is required. Retention of biopsy and specimen images should be compliant with federal and state policies, local health care facility procedures, and clinical need.

29 The radiologist who performs the procedure is responsi- 2.10. QUALITY CONTROL ble for obtaining pathology results and must determine AND IMPROVEMENT, SAFETY, if the lesion has been adequately biopsied. An adden- dum to the biopsy report should be produced by the INFECTION CONTROL, AND radiologist in charge of the biopsy or by his/her PATIENT EDUCATION CONCERNS Results of all imaging-guided percutaneous breast interventional procedures should be systematically Theseassigned results proxy should when be required communicated to expedite to the results.referring monitored and evaluated. Performance should be health(See RADIOLOGIC-PATHOLOGIC care professional or to the CORRELATION, patient, as appropri above).- correlated against established benchmarks. Please ate. These communications should be documented in refer to the Public Health Agency of Canada Report accordance with the CAR Standard for Communication from the Evaluation Indicators Working Group: of Diagnostic Imaging Findings. Guidelines for Monitoring Breast Screening Program Performance – Second Edition. 2.9. EQUIPMENT SPECIFICATIONS The number and type(s) of procedures, numbers of Breast ultrasound should be performed with a high- cancers and benign lesions and the number of repeat resolution real-time linear array scanner operating at a biopsies (including information on the reason and type center frequency of at least 10 MHz with pulsed, colour of needle) should be recorded for each facility and and power Doppler. Equipment permitting electronic individual radiologist. Additionally, the numbers of inconclusive or discordant results, inadequate samples, the highest frequency capable of adequate penetration and recommendations for re-biopsy or complete toadjustment the depth of of focal interest zone(s) should is recommended. be used. In general,

Stereotactic biopsy may be performed with a dedicated excision of a lesion should be recorded. be correlated in every instance and provisions for chair. All equipment must be calibrated as per the Imaging findings and pathologic interpretations should manufacturerprone setup or guidelines. with an add-on device and adjustable follow-up should be performed to detect and record false-negativereview of these and findings false-positive should results.be made. Biopsy

in the Breast Imaging MRI EQUIPMENT As with all interventional procedures, the procedure MRI equipment specifications are discussed should be fully described and the relative risks, limita-

SPECIFICATIONS section. to the patient. Informed consent should be recorded. Incidencetions, benefits, of complications and alternatives and should adverse be reactions, explained where known, should be recorded and periodically reviewed in order to identify opportunities to improve patient care.

Data should be collected in a manner which complies with the statutory and regulatory peer review proce-

review data. dures in order to protect confidentiality of the peer

30 3. NON-BIOPSY c) Contact info/pager # of radiologist INTERVENTION performing localization The radiologist should be available for discussion 3.1. PERIOPERATIVE LOCALIZATION at the time of surgery. AND IMAGING SURGICAL SPECIMEN IMAGING 86 HOOK WIRE Surgical specimen radiography should be performed for lesions which have been localized with image guidance. of an impalpable breast lesion. It should be performed If a lesion is visible sonographically, specimen sonogra- Wire localization is performed in order to guide excision phy can be performed. The pertinent imaging studies localization. As wire localization is a multidisciplinary should be available for review at the time of the speci- procedure,using a flexible there wire should specifically be ongoing designed communication for breast men image review, and this may require several days between the surgical team and the radiological team notice if prior images must be acquired. The radiologist regarding preferences for documentation and needle type. specimen images are responsible for the complete knowledgeplacing the ofwire all and/orpertinent his imaging. proxy interpreting If the patient the is Localization can be performed under either mam- being reviewed while under general anaesthetic, mographic, ultrasound or MRI guidance. Mammographic consideration should be given to the timeliness of the guidance can be either stereotactic or grid-based. Wire specimen review and the surgical team should coordi- placement should be performed the same day as the nate with the radiology team so that the radiologist is available at short notice to review the images. The surgery, in order to minimize the risk of wire migration. surgical excision and as close as possible to the time of specimen should be appropriately identified and The localization wire should be placed with the intent to marked for orientation by the surgical team. The lesion

the lesion. The shortest distance from the skin to the the lesion and the edge of the specimen should be lesiontraverse should the lesion be used and when extend possible. a short distanceFor large beyond lesions, reported,should be acknowledgingidentified, and thethe closestlimitations margins resulting between from the fact that specimen radiography imaging is often wire localization can be performed in order to roughly 2 dimensional. The specimen images should be compared particularly large clusters of calcifications, bracketing with the preoperative images in order to determine if the

outline the extent of the lesion with 2 or more wires.- device/clip in place, this should be noted, along with any mographic images should be gently performed pertinententire lesion details has of been placement. excised. If there is a localizing immediatelyOrthogonal (CC after and wire 90 degreeplacement. mediolateral) mam

Documentation of the localization should be forwarded should be communicated to the surgeon immediately. to the surgeon along with pre- and post-localization If it is felt that the lesion has not been fully excised, this breast images. Documentation may include a simple The pathologist should have access to the specimen diagrammatic representation of the localization, as images in order to identify areas of interest. well as pertinent measurements, including, but not RADIOACTIVE SEED LOCALIZATION87 RSL was developed to overcome some of the draw- limiteda) Identifying to: patient data and side of lesion b) Relationship between wire, lesion and breast betweenbacks of conventional ideal skin entry wire sites localization, for radiologists specifically, and the • size of lesion potential for transaction of the guide wire, the conflict •anatomic Total lengthlandmarks, of wire such as: facilitates breast surgery for the patient and makes • Length of wire below the skin leadsurgeons up procedures and scheduling more comfortable.difficulties. Overall, RSL • Distance from lesion to skin • Length of wire beyond lesion

31 Radioactive seed localization (RSL) is performed to architectural distortion seen and biopsied under ultrasound guidance) utilizes a titanium seed containing a small amount of radioactiveguide excision material of an thatimpalpable serves to breast allow localizationlesion. RSL of chemotherapy f)e) AllLesions lesions that biopsied may fulfill under criteria MRI guidancefor neo-adjuvant to RSL has been determined to comply with radiation g) Any lesion which may be confused with similar a breast lesion during surgery. Radiation exposure due

exposureLocalization regulations. can be performed under either ultrasound Noteadjacent that purposely lesions leaving behind suspicious microcal- or mammographic guidance. The seed should be placed this may result in under-sampling of the lesion. with mammography after the localization procedure. cifications as a “natural” marker is not recommended as within the lesion, and its position should be confirmed Where there is more than one clip placed in the same surgery. During surgery, a hand-held Geiger counter is breast, different shaped clips should be used at the Placement may be performed up to five days prior to biopsy site(s). a multidisciplinary procedure, there should be ongoing Post-biopsy mammograms are mandatory when a used to detect the specific location of the seed. As RSL is communication between the surgical team and the marker has been left in place during the biopsy. radiological team regarding preferences for documenta- Comments on the positioning of the marker, in tion, equipment, etc. relation to the location of the lesion biopsied should Documentation of the localization should be forwarded be included in the report. to the surgeon along with pre- and post-localization Radiopaque marker migration and misplacement may breast images. Documentation should include a simple occur following biopsy and can be troublesome if there diagrammatic representation of the localization as well lesion at biopsy88. has been complete excision of the visible portion of the asa) pertinentIdentifying measurements, patient data including, but not limited to: b) Size of lesion 3.2. ABSCESS DRAINAGE AND CYST c) Distance from lesion to skin ASPIRATION89 d) Contact info/pager # of radiologist Suspected abscess should be imaged with ultrasound. performing localization Percutaneous ultrasound drainage should be performed e) The radiologist should be available for if the cavity is less than 3 cm in size. Cavities greater discussion at the time of surgery than 3 cm in size may require catheter drainage and occasional surgical incision and drainage. An 18 gauge BIOPSY MARKERS or larger needle may be required90. Placement of a radiologically and/or ultrasound visible Percutaneous aspiration of a cyst may be performed in clip/marker or, alternatively, carbon-marking of the

a) Diagnostic uncertainty – complicated cyst vs. a the following situations: track is indicated in the following situations: solid mass if the solid mass would otherwise at follow up or subsequent localization need biopsy a)b) AnyComplete lesion or which near-complete may be difficult removal to identifyat sampling b) Painful cysts c) Cyst recurrence after a previous aspiration that the lesion is no longer recognizable with c) imagingModification (e.g., of small, the lesion solid afterintracystic biopsy lesions to an extent or d) Patient anxiety - d) Lesion for which the distribution or morphology 91. If mayclusters create of microcalcifications) ambiguity in the event that a wire- thereThe fluid are aspiratedany suspicious from featurescysts can such be discarded as sanguineous with localization is needed (e.g., multiple lesions, out pathology assessment if the fluid is non-bloody

fluidsent toor cytology. a non-collapsing lesion, a clip can be placed microcalcifications superimposing with other to localize the lesion and the fluid should be microcalcifications or asymmetric density/

32 Following abscess drainage, the patient and specimen RADIOFREQUENCY ABLATION94 should be dealt with in a manner consistent with the Radiofrequency ablation (RFA) is an upcoming protocol for abscess drainage care at the institution at technology that has been developed as a minimally which the procedure was performed. invasive option for the treatment of breast masses. The treatment utilizes frictional heat generated by 3.3. IMAGE-GUIDED BREAST an electrode placed within a mass. Radiofrequency THERAPY ablation is performed under real-time ultrasound The following technologies are a selection of breast guidance and monitoring. imaging and/or treatment options that are currently RFA has demonstrated promising results in tumours active areas of research. Though widely investigated within liver, brain, kidney, pancreas and prostate tissue. and reported upon, these technologies are not wide- Initial trials using RFA for the treatment of breast cancer spread in use and require additional investigations have yielded high rates of tumour destruction and low before they can be incorporated into common practice. complication rates, however more research is needed. This guide serves simply as an introduction to these techniques. CRYOSURGERY95 Cryosurgery is an ablation procedure that uses freez- 92 HIGH INTENSITY FOCUSED ULTRASOUND ing to destroy diseased tissue. Cryoablation treatment High intensity focused ultrasound (HIFU) is a non- is minimally invasive and locally destroys target tissue invasive therapy option that has recently been without requiring resection. Cryoablation surgery can developed. HIFU provides an alternative to surgical also be used to encompass a non-palpable tumour in - order to provide a palpable marker for surgeons before sound beams to create heat and selectively cause cell resection. Cryoablation surgery is advantageous over interventions by using external high intensity ultra other ablation techniques as the phase change that Magnetic Resonance Imaging (MRI) is used to guide occurs during ice formation can be visualized on death without compromising any external tissue. and monitor the therapy. This non-invasive technique ultrasound, the modality most commonly used to is thought to be more psychologically and cosmetically undertake and monitor the treatment. acceptable to patients, and more suitable for treating patients who are not (ideal) surgical candidates. treat benign breast abnormalities and is currently Research has shown that HIFU has the potential to Cryoablation surgery has been used extensively to provide a non-invasive replacement for lumpectomy. malignant tumours. It has not however, been conclusively shown that the being explored as a potential therapy option for destruction of malignant breast tissue using HIFU is 3.4. QUALIFICATIONS AND equivalent to conventional surgery outcomes. A HIFU treatment method has recently gained FDA approval RESPONSIBILITIES OF PERSONNEL FOR BREAST INTERVENTION for breast HIFU. Radiologist, technologist, sonographer, and MR tech- for treating uterine fibroids, a promising development nologist credentials are discussed in the Breast LASER INTERSTITIAL THERAPY93 Imaging section of this document. Laser interstitial therapy (LITT) is a minimally-invasive therapy option that uses laser energy to hyperthermically cause cell death to a target tissue volume [1]. LITT in For MRI guided breast interventions there are specific breast is commonly administered using stereotactic additional requirements: the radiologist must be - guidance but is also performed using magnetic resonance encequalified in performing to interpret percutaneous Breast MRI, havebreast a minimumbiopsies. of imaging (MRI) as well as stereotactically. To date a 3 hours of CME in breast MRI intervention and experi considerable amount of research surrounding LITT breast MRIs every 2 years, alone or with supervision methods has involved theoretical or animal models. fromMaintenance another ofradiologist, certification 3 hours requires of Breast performing MRI biopsy 6 CME every 3 years, and radiologic-pathologic correla- tion of all biopsies.

33 3.5. SPECIFICATIONS OF THE Post-procedure imaging should be performed. EXAMINATION - The decision to perform an interventional procedure cations are within the area of interest of if there has Mammographic images should be performed if calcifi should conform to the general principles noted above. been placement of a radiopaque marker or wire. If ultrasound guidance is used, a pre-procedure plan- 3.6. DOCUMENTATION including the area of concern and, particularly if there A permanent record of interventional procedures ning ultrasound examination should be performed, should be documented on a retrievable image storage stereotactic guidance is used, pre-procedure images shouldis suspicion be obtained, of malignancy, ensuring the that axillary the area regions. of concern If type of procedure performed. Retention of procedure is located within the region of the paddle fenestration. imagingformat. Specific should bedetails compliant of documentation with federal varyand provinwith the- cial policies, with local health care facility procedures, and with clinical need. well as alternative procedures should be discussed withBenefits, the patient.limitations, Informed and risks consent of the should procedure be obtained as The radiologist who performs the procedure is respon- and documented. sible for obtaining any pathology results and must determine if the lesion has been adequately aspirated, The breast, the probe or stereotactic equipment, and biopsied, localized or ablated.

should be prepared in conformity with the principles These communications should be documented in ofthe cleanliness field in which to minimize the procedure the risk is toof infection.be performed accordance with the CAR Standard for Communication of Diagnostic Imaging Findings. For ultrasound-guided intervention, the skin entry site 3.7. EQUIPMENT SPECIFICATIONS colour Doppler before biopsy. Any sizeable artery Breast ultrasound should be performed with a high- and projected needle path should be evaluated with should be avoided. Using a high-frequency transducer, resolution and real-time linear array scanner operating continuous visualization of the needle is possible and at a center frequency of at least 10 MHz with pulsed, desirable. The length of the needle, particularly the tip, colour and power Doppler. Equipment permitting

immediately prior to and during deployment of a In general, the highest frequency capable of adequate should be visible during the examination, particularly penetrationelectronic adjustment to the depth of focal of interest zone(s) should is recommended. be used. as parallel to the chest wall as possible. spring-loaded device. The needle axis should be kept Stereotactic localization may be performed with a For stereotactic intervention, the operating dedicated prone setup or with an add-on device and radiologist must perform or supervise lesion targeting. Needle/wire position should be imaged the manufacturer and must also undergo calibration during targeting and sampling. andadjustable acceptance chair. testing All equipment by the medical must be physicist. calibrated by

Documentation of needle/wire position during the procedure or after localization should be retained as in the Breast Imaging MRI EQUIPMENT part of the medical record. MRI equipment specifications are discussed If using ultrasound guidance, compression should SPECIFICATIONS section. be applied after each needle pass. Hemostasis should be achieved, using direct compression, after the procedure has been completed.

34 3.8. QUALITY CONTROL AND IMPROVEMENT, SAFETY, INFECTION CONTROL, AND PATIENT EDUCATION CONCERNS Results of all imaging-guided percutaneous breast interventional procedures should be systematically monitored and evaluated. Performance should be correlated against established benchmarks. Please refer to the Public Health Agency of Canada Report from the Evaluation Indicators Working Group: Guidelines for Monitoring Breast Screening Program Performance – Second Edition. The numbers of procedures should be kept for each institution and each radiologist. Where possible, follow-up should include any instances of failed procedure and/or post-procedure infection.

As with all interventional procedures, the procedure should be fully described and the relative risks, limita- to the patient. Informed consent should be recorded. Incidencetions, benefits, of complications and alternatives and should adverse be reactions, explained where known, should be recorded and periodically reviewed in order to identify opportunities to improve patient care.

Data should be collected in a manner which complies with the statutory and regulatory peer review proce- review data. dures in order to protect confidentiality of the peer

35 APPENDIX A – BI-RADS® AND OTHER REPORTING AND DATA RESOURCES

The American College of Radiology developed BI-RADS® as a means of standardizing terminology, reporting and assessment for mammography, ultrasound and MRI. Details on data collection and auditing of results as well as peer review and quality assurance are included in this document. The complete BI-RADS® Atlas includes

documentdetails and (www.acr.org explanations) isbeyond recommended. the scope Links of this are includeddocument at andthe endreferral of this to document. excerpted A text full fromversion that of the BI-RADS® Atlas is available for purchase from the ACR.

assessment categories as outlined in the BI-RADS® Atlas. All Breast Imaging reports should use the lexicon and The Canadian Breast Cancer Screening Initiative and the Quality Determinants Working Group through the Public Health Agency of Canada have developed several relevant documents, including Quality Determinants of Organized Screening Programs in Canada and Guidelines for Monitoring Breast Screening Program Performance. These documents also include details on auditing as well as core indicators relevant to screening programs and diagnostic breast imaging. These documents are regularly updated to reflect current practice and standards. In addition to following the links above, these can be accessed at the Public Health Agency of Canada website (http://www.phac-aspc.gc.ca).

36 RELEVANT LINKS

Canadian Association of Radiologists (www.car.ca) Canadian Association of Radiologists Mammography Accreditation Program (http://www.car.ca/en/accreditation/map.aspx)

American College of Radiology (www.acr.org) ACR BI-RADS® Atlas Mammography Fourth edition (http://www.acr.org/Quality-Safety/Resources/BIRADS/Mammography) ACR BI-RADS® Atlas Ultrasound First edition (http://www.acr.org/Quality-Safety/Resources/BIRADS/Ultrasound) ACR BI-RADS® Atlas MRI First edition (http://www.acr.org/Quality-Safety/Resources/BIRADS/MRI) ACR Breast MRI Accreditation Requirements (http://www.acr.org/Quality-Safety/Accreditation/BreastMRI) ACR Breast Imaging and Intervention Practice Guidelines and Technical Standards (http://www.acr.org/Quality-Safety/Standards-Guidelines) ACR Appropriateness Criteria® (http://www.acr.org/Quality-Safety/Appropriateness-Criteria) ACR, SBI Statement on ACRIN Breast Ultrasound Trial Results and Role of Ultrasound in Breast Imaging Care (http://www.acr.org/About-Us/Media-Center/Position-Statements/Position-Statements-Folder/ ACR-Statement-Regarding-the-Digital-Mammographic-Imaging-Screening-Trial-DMIST-Results)

(http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/US_Breast.pdf) AIUM Practice Guideline for the Performance of a Breast Ultrasound Examination Public Health Agency of Canada. Program Performance Measures (http://www.phac-aspc.gc.ca/publicat/2007/gmbspp-ldsppdcs/pdf/gmbspp-ldsppdcs_e.pdf) Health Canada Canadian Mammography Quality Guidelines (http://www.hc-sc.gc.ca/ewh-semt/pubs/radiation/02hecs-sesc267/index-eng.php) MDALL – Your reference tool for licensed medical devices in Canada (www.mdall.ca) Integrating the Healthcare Enterprise (www.ihe.net) IBIS Breast Cancer risk evaluation tool (http://www.ems-trials.org/riskevaluator/) The National Comprehensive Cancer Network (NCCN)® (www.nccn.org)

37 ENDNOTES

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