Background: Lesion stiffness measured by shear wave elastography has shown to effectively separate benign from malignant breast masses. The aim of this study was to evaluate different aspects of Comb-push Ultrasound Shear Elastography (CUSE) performance in differentiating breast masses.
Methods: With written signed informed consent, this HIPAA- compliant, IRB approved prospective study included patients from April 2014 through August 2016 with breast masses identified on conventional imaging. Data from 223 patients (19-85 years, mean 59.93±14.96 years) with 227 suspicious breast masses identifiable by ultrasound (mean size 1.83±2.45cm) were analyzed. CUSE was performed on all patients. Three regions of interest (ROI), 3 mm in diameter each, were selected inside the lesion on the B-mode ultrasound which also appeared in the corresponding shear wave map. Lesion elasticity values were measured in terms of the Young's modulus. In correlation to pathology results, statistical analyses were performed.
Results: Pathology revealed 108 lesions as malignant and 115 lesions as benign. Additionally, 4 lesions (BI-RADS 2 and 3) were considered benign and were not biopsied. Average lesion stiffness measured by CUSE resulted in 84.26% sensitivity (91 of 108), 89.92% specificity (107 of 119), 85.6% positive predictive value, 89% negative predictive value and 0.91 area under the curve (P<0.0001). Stiffness maps showed spatial continuity such that maximum and average elasticity did not have significantly different results (P > 0.21).
Conclusion: CUSE was able to distinguish between benign and malignant breast masses with high sensitivity and specificity. Continuity of stiffness maps allowed for choosing multiple quantification ROIs which covered large areas of lesions and resulted in similar diagnostic performance based on average and maximum elasticity. The overall results of this study, highlights the clinical value of CUSE in differentiation of breast masses based on their stiffness.