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: 21.5%, 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.