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Diagnostic Accuracy of Shear Wave Elastography for Prediction of Breast Malignancy in Patients with Pathological Nipple Discharge

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Diagnostic Accuracy of Shear Wave Elastography for Prediction of Breast Malignancy in Patients with Pathological Nipple Discharge Open Access Research BMJ Open: first published as 10.1136/bmjopen-2015-008848 on 22 January 2016. Downloaded from Diagnostic accuracy of shear wave elastography for prediction of breast malignancy in patients with pathological nipple discharge Xiaobo Guo,1 Ying Liu,1 Wanhu Li2 To cite: Guo X, Liu Y, Li W. ABSTRACT Strengths and limitations of this study Diagnostic accuracy of shear Objectives: Pathological nipple discharge (PND) may wave elastography for indicate malignant breast lesions. As the role of shear ▪ prediction of breast Diagnostic accuracy of shear wave elastography wave elastography (SWE) in predicting these malignant malignancy in patients with (SWE) for detecting malignancy of patients with pathological nipple discharge. lesions has not yet been evaluated, we aim to evaluate PND has rarely been studied. BMJ Open 2016;6:e008848. the diagnostic value of SWE for this condition. ▪ For the first time, this study tested diagnostic doi:10.1136/bmjopen-2015- Design: Prospective diagnostic accuracy study accuracy of a synthesised measurement of quali- 008848 comparing a combination of qualitative and quantitative tative and quantitative measures of SWE for measurements of SWE (index test) to a ductoscopy detecting malignancy in patients with PND. ▸ Prepublication history for and microdochectomy for histological diagnosis ▪ Limitations include the fact that the weight of this paper is available online. (reference test). each measurement in the synthesised score was To view these files please Setting: Fuzhou General Hospital of Nanjing military assigned evenly and the surgeon was not visit the journal online command. blinded. (http://dx.doi.org/10.1136/ Participants: A total of 379 patients with PND were bmjopen-2015-008848). finally included from January, 2011 to March 2014, after we screened 1084 possible candidates. All INTRODUCTION Received 21 May 2015 In 2014, the American Cancer Society Revised 13 October 2015 participants were evaluated through SWE, with Accepted 2 November 2015 qualitative parameters generated by Virtual Touch reported 235 030 new cases of breast cancer 1 http://bmjopen.bmj.com/ tissue imaging (VTI) and quantitative parameters and 40 430 breast cancer-related deaths. generated by Virtual Touch tissue quantification (VTQ). The prevalence rate of breast cancer is the All the patients were consented to receive a highest of all types of malignant carcinoma ductoscopy and microdochectomy for histological in Chinese women.2 The cases of Chinese diagnosis, and the results were set as a reference test. women with breast cancer account for 12.2% Outcome measures: Sensitivity and specificity of the of all newly diagnosed breast cancer around combined VTI and VTQ of the SWE for detection of the world and 9.6% of deaths from breast malignancy in patients with PND. cancer.2 Results: The 379 participants presented with 404 on September 26, 2021 by guest. Protected copyright. Pathological nipple discharge (PND) is the lesions. The results of pathological examination third most common symptom of patients, showed that 326 (80.7%) of the 404 lesions were prompting referral to doctors for breast dis- benign and the other 78 (19.3%) were malignant. An 3 area under the curve of elasticity score, VTQm and eases. PND is believed to be an indicator for VTQc, were 0.872, 0.825 and 0.857, respectively, with breast carcinoma, especially when the nipple 3 the corresponding cut-off point as 2.50, 2.860 m/s and discharge is bloody. Mastectomies were 1Department of 3.015 m/s, respectively. After a combination of these unnecessarily carried out without obtaining a Ultrasonography, 476 Clinical measurements, the sensitivity, specificity, and positive histopathological diagnosis before the year Department, Fuzhou General and negative predictive value (PPV and NPV), were 1950. Although mastectomies are not neces- Hospital of Nanjing Military 89.7%, 72.1%, 43.5% and 96.7%, respectively. The sarily needed nowadays, patients with PND Region, Fuzhou, China sensitivity analysis showed 82% of the sensitivity and 2Department of Radiology, would normally be advised to undergo 96.8% of the specificity, in which patients with no further examinations to rule out breast Shandong Cancer Hospital pathological findings in ductoscopy were excluded. and Institute, Jinan, China malignancy. These examinations involve Conclusions: Ultrasonographic elastography is mammography, ultrasonography, ductoscopy sensitive for patients with PND and could be used as a Correspondence to with or without galactography, as well as cyto- Dr Xiaobo Guo; triage test before ductoscopy examination. Studies for [email protected] and further improvement of diagnostic sensitivity are logical tests. Mammography and B-mode Wanhu Li; warranted. ultrasonography (BUS) are used for screen- [email protected] ing patients with high risk of breast Guo X, et al. BMJ Open 2016;6:e008848. doi:10.1136/bmjopen-2015-008848 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2015-008848 on 22 January 2016. Downloaded from carcinoma, but they are not sensitive enough for detect- inclusion criteria: (1) an age over 18 years; (2) with or ing malignancy in patients with PND, since small lesions without palpable breast masses; (3) agreeing to partici- may be occult with these two modalities.4 Ductoscopy pate in this study; (4) providing written consent for and microdochectomy are the gold standard for diagno- further examination, biopsy and use of the study data. sis of malignancy in patients with PND.56In clinical We excluded participants who (1) refused to receive a practice, patients with PND are conventionally advised a ductoscopy and microdochectomy or a biopsy; (2) had ductoscopy, but ductoscopy and microdochectomy are serious damage of internal organs, which could poten- invasive examinations with high cost, so some patients tially bias the results; (3) could not receive local anaes- refuse ductoscopy and turn to other non-invasive tests thesia because of allergy; (4) were taking or had taken instead. Cytological tests can only be used as supportive chemotherapy or radiotherapy for malignant breast evidence.7 Therefore, a triage test is needed before tumours. patients with PND are asked to take a ductoscopy and microdochectomy examination. Ultrasonographic imaging Ultrasonographic elastography works through the Eligible participants were asked to take ultrasonographic assumption that tissue compression produces strain examinations before undergoing ductoscopy and microdo- within the tissue, and that the strain is less in firm tissue chectomy. The ultrasonographic examinations included a than in soft tissue. So the firmness of the tissue to predict BUS and an elastography with acoustic radiation force malignancy can be evaluated through measuring the impulse (ARFI), which were performed with a Siemens tissue strain ratio, which is usually measured as elasticity.8 ACUSON S2000 ultrasonographic system (Siemens Ltd, Recently, several studies indicated that ultrasonographic China, product standard: YZB/USA 3876–2010). One elastography may be a useful tool for differentiating operator (with 10 years of experience in ultrasonography benign and malignant masses. The sensitivity of predict- imaging) ran the BUS and the ARFI to get the BUS and ing malignancy in patients with breast lesions ranges elastography images, using a superficial probe (9L4, from 80% to 98%, while the specificity ranges from 66% Siemens Ltd, China) with a frequency of 4–9Hz. – to 84%.9 14 Recently, a shear wave elastography (SWE) The BUS images of the breast lesions were obtained was reported to be less operator-dependent, and predict- and categorised according to the Breast Imaging ive of ductal or intraductal carcinoma.81516A five-level Reporting and Data System (BI-RADS). In the BI-RADS, elasticity score is normally used for qualitative assessment the number 1 refers to negative findings; number 2 of the images of elastography, while a quantitative meas- refers to benign findings; number 3 refers to probably urement of elastography is also becoming popular; a benign findings; number 4 refers to suspicious malig- combination of these ultrasonic measurements seems to nancy; and number 5 is highly suggestive of malignancy. be beneficial for improving diagnostic accuracy of breast Moreover, we applied a subclassification scheme for malignancies.816We noticed that the diagnostic value of BI-RADS 4: (1) 4A: low suspicious for malignancy; (2) http://bmjopen.bmj.com/ SWE to detect malignancy in patients with PND has 4B: intermediate suspicious for malignancy; (3) 4C: rarely been studied, especially with a combination of moderate concern, but not classic for malignancy.18 Two qualitative and quantitative measurements of SWE. So we radiologists (XBG and YL, who each have at least 5 years conducted a study aiming to find out the sensitivity and of experience in ultrasonography) independently specificity accuracy of SWE for predicting malignancy in assessed the BUS images for the following aspects: the patients with PND. shape of the mass, its depth, orientation and margin, boundary of the lesions, echo pattern, posterior acoustic features as well as surrounding tissue changes. All the on September 26, 2021 by guest. Protected copyright. METHODS AND MATERIALS detected masses were divided into two types (solid and This study is designed for evaluating the diagnostic cystic) according to the presence of a cystic portion. In accuracy of SWE for detection of malignancy in patients cases involving a solid mass in a dilated duct (intraduc-
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