Evaluation of Screening US-detected Breast Masses by Combined Use of Elastography and Color Doppler US with B-Mode US in Women with Dense Breasts: A Multicenter Prospective Study

Abstract

Purpose To investigate the value of the combined use of elastography and color Doppler ultrasonography (US) with B-mode US for evaluation of screening US–detected breast masses in women with dense breasts.

Materials and Methods This prospective, multicenter study included asymptomatic women with dense breasts who were referred for screening US between November 2013 and December 2014. Eligible women had a newly detected breast mass at conventional B-mode US screening, for which elastography and color Doppler US were performed. The following outcome measures were compared between B-mode US and the combination of B-mode US, elastography, and color Doppler US: area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value (PPV), and the number of false-positive findings at screening US.

Results Among 1021 breast masses (mean size, 1.0 cm; range, 0.3–3.0 cm) in 1021 women (median age, 45 years), 68 were malignant (56 invasive). Addition of elastography and color Doppler US to B-mode US increased the AUC from 0.87 (95% confidence interval [CI]: 0.82, 0.91) to 0.96 (95% CI: 0.95, 0.98; P < .001); specificity from 27.0% (95% CI: 24.2%, 29.9%) to 76.4% (95% CI: 73.6%, 79.1%; P < .001) without loss in sensitivity (95% CI: −1.5%, 1.5%; P > .999); and PPV from 8.9% (95% CI: 7.0%, 11.2%) to 23.2% (95% CI: 18.5%, 28.5%; P < .001), while avoiding 67.7% (471 of 696) of unnecessary biopsies for nonmalignant lesions.

Conclusion Addition of elastography and color Doppler US to B-mode US can increase the PPV of screening US in women with dense breasts while reducing the number of false-positive findings without missing cancers.