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Original Research

Shear-wave Elastography Improves the Specificity of Breast US: The BE1 Multinational Study of 939 Masses

Published Online:Feb 1 2012https://doi.org/10.1148/radiol.11110640

Abstract

Adding consideration of mass stiffness, as determined with shear-wave elastographic qualitative or quantitative features, can help reduce unnecessary biopsies of low-suspicion Breast Imaging Reporting and Data System category 4a masses.

Purpose

To determine whether adding shear-wave (SW) elastographic features could improve accuracy of ultrasonographic (US) assessment of breast masses.

Materials and Methods

From September 2008 to September 2010, 958 women consented to repeat standard breast US supplemented by quantitative SW elastographic examination in this prospective multicenter institutional review board–approved, HIPAA-compliant protocol. B-mode Breast Imaging Reporting and Data System (BI-RADS) features and assessments were recorded. SW elastographic evaluation (mean, maximum, and minimum elasticity of stiffest portion of mass and surrounding tissue; lesion-to-fat elasticity ratio; ratio of SW elastographic–to–B-mode lesion diameter or area; SW elastographic lesion shape and homogeneity) was performed. Qualitative color SW elastographic stiffness was assessed independently. Nine hundred thirty-nine masses were analyzable; 102 BI-RADS category 2 masses were assumed to be benign; reference standard was available for 837 category 3 or higher lesions. Considering BI-RADS category 4a or higher as test positive for malignancy, effect of SW elastographic features on area under the receiver operating characteristic curve (AUC), sensitivity, and specificity after reclassifying category 3 and 4a masses was determined.

Results

Median participant age was 50 years; 289 of 939 (30.8%) masses were malignant (median mass size, 12 mm). B-mode BI-RADS AUC was 0.950; eight of 303 (2.6%) BI-RADS category 3 masses, 18 of 193 (9.3%) category 4a lesions, 41 of 97 (42%) category 4b lesions, 42 of 57 (74%) category 4c lesions, and 180 of 187 (96.3%) category 5 lesions were malignant. By using visual color stiffness to selectively upgrade category 3 and lack of stiffness to downgrade category 4a masses, specificity improved from 61.1% (397 of 650) to 78.5% (510 of 650) (P < .001); AUC increased to 0.962 (P = .005). Oval shape on SW elastographic images and quantitative maximum elasticity of 80 kPa (5.2 m/sec) or less improved specificity (69.4% [451 of 650] and 77.4% [503 of 650], P < .001 for both), without significant improvement in sensitivity or AUC.

Conclusion

Adding SW elastographic features to BI-RADS feature analysis improved specificity of breast US mass assessment without loss of sensitivity.

© RSNA, 2012

Clinical trial registration no. NCT00716482

Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11110640/-/DC1

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Article History

Received April 7, 2011; revision requested May 25; final revision received July 26; accepted August 18; final version accepted September 6.
Published online: Feb 2012
Published in print: Feb 2012