Evaluation of standard breast ultrasonography by adding two-dimensional and three-dimensional shear wave elastography: a prospective, multicenter trial

Abstract

Abstract Objective To reduce the number of biopsies performed on benign breast lesions categorized as BI-RADS 4–5, we investigated the diagnostic performance of combined two-dimensional and three-dimensional shear wave elastography (2D + 3D SWE) with standard breast ultrasonography (US) for the BI-RADS assessment of breast lesions. Methods A total of 897 breast lesions, categorized as BI-RADS 3–5, were subjected to standard breast US and supplemented by 2D SWE only and 2D + 3D SWE analysis. Based on the malignancy rate of less than 2% for BI-RADS 3, lesions assessed by standard breast US were reclassified with SWE assessment. Results After standard breast US evaluation, 268 (46.1%) participants underwent benign biopsies in BI-RADS 4–5 lesions. By using separated cutoffs for upstaging BI-RADS 3 at 120 kPa and downstaging BI-RADS 4a at 90 kPa in 2D + 3D SWE reclassification, 123 (21.2%) participants underwent benign biopsy, resulting in a 54.1% reduction (123 versus 268). Conclusion Combining 2D + 3D SWE with standard breast US for reclassification of BI-RADS lesions may achieve a reduction in benign biopsies in BI-RADS 4–5 lesions without sacrificing sensitivity unacceptably. Clinical relevance statement Combining 2D + 3D SWE with US effectively reduces benign biopsies in breast lesions with categories 4–5, potentially improving diagnostic accuracy of BI-RADS assessment for patients with breast lesions. Trial registration ChiCTR1900026556 Key Points • Reduce benign biopsy is necessary in breast lesions with BI-RADS 4–5 category. • A reduction of 54.1% on benign biopsies in BI-RADS 4–5 lesions was achieved using 2D + 3D SWE reclassification. • Adding 2D + 3D SWE to standard breast US improved the diagnostic performance of BI-RADS assessment on breast lesions: specificity increased from 54 to 79%, and PPV increased from 54 to 71%, with slight loss in sensitivity (97.2% versus 98.7%) and NPV (98.1% versus 98.7%).