Michael Golatta

Objectives We evaluated whether lesion‐to‐fat ratio measured by shear wave elastography in patients with Breast Imaging Reporting and Data System (BI‐RADS) 3 or 4 lesions has the potential to further refine the assessment of B‐mode ultrasound alone in breast cancer diagnostics. Methods This was a secondary analysis of an international diagnostic multicenter trial (NCT02638935). Data from 1288 women with breast lesions categorized as BI‐RADS 3 and 4a–c by conventional B‐mode ultrasound were analyzed, whereby the focus was placed on differentiating lesions categorized as BI‐RADS 3 and BI‐RADS 4a. All women underwent shear wave elastography and histopathologic evaluation functioning as reference standard. Reduction of benign biopsies as well as the number of missed malignancies after reclassification using lesion‐to‐fat ratio measured by shear wave elastography were evaluated. Results Breast cancer was diagnosed in 368 (28.6%) of 1288 lesions. The assessment with conventional B‐mode ultrasound resulted in 53.8% (495 of 1288) pathologically benign lesions categorized as BI‐RADS 4 and therefore false positives as well as in 1.39% (6 of 431) undetected malignancies categorized as BI‐RADS 3. Additional lesion‐to‐fat ratio in BI‐RADS 4a lesions with a cutoff value of 1.85 resulted in 30.11% biopsies of benign lesions which correspond to a reduction of 44.04% of false positives. Conclusions Adding lesion‐to‐fat ratio measured by shear wave elastography to conventional B‐mode ultrasound in BI‐RADS 4a breast lesions could help reduce the number of benign biopsies by 44.04%. At the same time, however, 1.98% of malignancies were missed, which would still be in line with American College of Radiology BI‐RADS 3 definition of <2% of undetected malignancies.