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First Evaluation of the Diagnostic Accuracy of an Automated 3D Ultrasound System in a Breast Screening Setting

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First Evaluation of the Diagnostic Accuracy of an Automated 3D Ultrasound System in a Breast Screening Setting ANTICANCER RESEARCH 31: 2569-2574 (2011) First Evaluation of the Diagnostic Accuracy of an Automated 3D Ultrasound System in a Breast Screening Setting FRANK STÖBLEN1, SOLVEIG LANDT2, RUTH STELKENS-GEBHARDT1, JALID SEHOULI3, MAHDI REZAI4 and SHERKO KÜMMEL5 1Department of Radiology, Hyssensstift Kliniken-Essen-Mitte, Essen, Germany; 2Department of Gynecology and Obstetrics, University Hospital Düsseldorf, Düsseldorf, Germany; 3Department of Gynecology and Obstetrics, Charité University Hospital Berlin, Berlin, Germany; 4Breast Center, Luisenkrankenhaus, Düsseldorf, Germany; 5Breast Center, Huyssensstift Kliniken Essen-Mitte, Essen, Germany Abstract. Background/Aim: Automated ultrasound examination 40 years of age; for the assessment of mammographically of suspicious findings can reduce the physician’s workload in suspicious lesions (ACR 3-4, BI-RADS 0, III, IV and V) screening mammography. The present study examines the detected after clinical suspicion (40-49 and over 70 years) or diagnostic accuracy of this method in comparison to routine screening mammography (50-69 years); and for mammography as the reference standard for the first time. interventional biopsy in BI-RADS IV/V lesions. Patients and Methods: A total of 304 patients underwent Presently, ultrasound examination is not recommended as automated 3D ultrasound examination after screening the sole method of breast cancer screening. mammography. Mammograms and ultrasound images were Like ultrasound in general, sonographic breast diagnosis assessed by independent examiners, and sensitivity, specificity can be extremely accurate (3), but its quality depends not and the degree of agreement between both methods were only on a highstandard of technical equipment (1, 2), but calculated. Results: The degree of agreement was moderate also on the proficiency, experience and diligence of the (Cohen’s κ=0.130 for all and 0.153 for positive/negative examiner (4). When performed thoroughly, the examination ratings), mainly owing to a high percentage of false-positive requires approximately 20 minutes of physician time ultrasound results. However, the results of sonographical re- according to the recently published results of the ACRIN examination of suspicious mammograms were favorable. The 6666 study (5). only two undetected proven malignant lesions were Another potential pitfall is the fact that sonography results microcalcified, and in three more cases with disagreement, the are not automatically stored, limiting the possibilities for ultrasound diagnosis was correct. Conclusion: Automated 3D review under diagnostic, but also forensic aspects. ultrasound imaging appears to be on a par with hand-held Since breast cancer screening is a setting with high ultrasound in terms of diagnostic quality. economical impact, an optimized relationship between cost and benefit is of pivotal importance, and the reduction of Ultrasound examination of the breast has evolved into an physician time can be a means to this end, directing research indispensable diagnostic tool for early detection of breast focus on automated diagnostic systems that can be applied cancer since its introduction in the 1950s (1). According to by medical technicians or assistants (6). current guidelines in Germany, ultrasound examination is A relatively recent development in ultrasound diagnostics of recommended in the following situations (2): As a first-line the breast is the possibility for automated 3D real-time imaging method for the assessment of palpable lesions in women under that offers a number of potentially significant advantages over conventional ultrasound (1, 7, 8): Improved differentiation of architectural distortion, especially in the ’bird’s eye’ view; better appreciation of tumour volume, indispensable for Correspondence to: Frank Stöblen, Department of Radiology, monitoring of patients under neo-adjuvant treatment regimens; Hyssensstift Kliniken-Essen-Mitte, Henricistrasse 92, 45136 Essen, storage of the complete imaging data for off-line expert review Germany. Tel: +49 020117435001, Fax: +49 020117435000, e-mail: [email protected] and image processing; securing of complete volume coverage; and reduction of physician time, i.e. cost. Key Words: Breast cancer, screening, mammography, ultrasound, Presently the rationale for automated 3D imaging in breast automated 3D imaging. cancer screening in addition to or instead of conventional 0250-7005/2011 $2.00+.40 2569 ANTICANCER RESEARCH 31: 2569-2574 (2011) ultrasound techniques is unclear, and clinical experience is Table I. Contingency tables of mammography and breast scanner results rather limited (7-10). The issue of a possible application of (identical classification in grey fields). automated ultrasound breast examination for the screening Positive/negative Ultrasound BI-RADS of dense breasts in addition to mammography is, however κ=0.153 relevant, not the subject of the present study; rather this I-III IV-V Total study examines the diagnostic accuracy of automated ultrasound breast examination in comparison to Mammography ¥ mammography as the reference standard. BI-RADS I-II 230 60 290 IV 5¥ 914 Total 235 69 304 Patients and Methods All ratings Ultrasound BI-RADS Patients. Patients were recruited for the trial between August 26th κ=0.130 and November 10th, 2008. All women attending the diagnostic I II III IV V Total centre for screening mammography [which is funded by compulsory health insurance (CHI) on a bi-annual basis for women of 50-69 Mammography years of age in Germany] during this period were eligible, and 310 BI-RADS† I 114 34 26 35 11 220 consecutive patients were considered for participation. II 33 13 10 10 4 70 ‡ $ Breast density was not a criterion for enrolment; patients with IV 2 1§ 2 54 14 densities ACR 1-4 were enrolled, and the majority were classified Total 149 48 38 50 19 304 as ACR 2 (’fat with some fibroglandular tissue’). †Conference decision where applicable; ‡one microcalcified DCIS, in Informed consent (oral and written) was obtained from all patients, one case ultrasound correct, no tumor; §ultrasound correct, cyst; $one and no patient refused participation after receiving the information microcalcified DCIS, in one case ultrasound correct, benign. ¥ 2 regarding the study. Pre-menopausal patients were questioned about microcalcified DCIS, US correct in three cases. the possibility of pregnancy, which was denied by all. The study met the criteria of ‘Good Clinical Practice’ and the principles of the Declaration of Helsinki. Patients were between 50.1 and 69.8 years of age upon examination (mean 58.3±6.4 years). The diagnostic procedure was The breast scanner images were evaluated by an independent completed in 304 patients per protocol; the patient data was made investigator who was oblivious to the mammography results. anonymous and processed for statistical evaluation. Each case of disagreement (with regard to BI-RADS Data collection was planned before the breast scanner and classification) between two investigators was reviewed by an mammographic examinations were performed, i.e. the study was external senior radiologist otherwise uninvolved in the study, and a prospective. conference decision was made. As part of the regular screening follow-up (2), patients were re- Diagnostic procedures. After declaring informed consent, patients examined at 6-monthly intervals; none of these re-examinations led first underwent mammography with the Mammomat NovationDR to the reversal of a diagnosis made during the study. Patients with full-field digital system in combination with the syngo Acquisition unsuspicious mammographies, but suspicious ultrasound findings, Workstation (AWS) and MammoReport breast care workplace were re-examined, but the results of this re-examination were not (Siemens Healthcare, Erlangen, Germany). This system is part of the present study. nationally and internationally approved for breast cancer screening. Statistical data evaluation. After completion of the last patient’s According to the manufacturer’s recommendations, the W/Rh examination the following information was entered for data target/filter combination was employed for all breast types even processing and evaluation: Patients’ age and date of examination; though Mo/Mo and Mo/Rh target/filter combinations are also medical history (previous examinations or treatments of the breasts); available. All examinations were performed under automatic mammography results (tissue density, classification of lesions, if exposure control (AEC). any); and ultrasound results (description, size, localisation and After completion of mammography, automated 3D ultrasound histological characteristics of lesions [if any], BI-RADS examination was performed with a SomoVu device (U-Systems, San classification). Jose, CA, USA in technology and distribution collaboration with The diagnostic accuracy of the automated ultrasound scanning Siemens Health Care Inc., Ultrasound Division, Mountain View, system was assessed in comparison with mammography as the CA, USA). This system allows automated acquisition of multi-plane reference standard, and data was analysed according to the ultrasound images of the breast by serial images in a volume of up Standards for Reporting of Diagnostic Accuracy (STARD) to 14.5×17×5 cm. The images are interpreted at the BreastView recommendations (11). workstation. For the statistical analysis, the STATISTICA software package In contrast to standard screening procedure, mammographies was employed (StatSoft, Tulsa, OK, USA). Sensitivity
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