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Purpose: To prospectively evaluate the sensitivity and specificity of ultrasonographic (US) strain imaging for distinguishing between benign and malignant solid breast masses, with biopsy results as the reference standard.

Materials and Methods: The study was institutional review board approved and HIPAA compliant. Informed consent was obtained from all participating patients. US strain imaging of 403 breast masses was performed. The 50 malignant and 48 benign lesions (in patients aged 19–83 years; mean age, 49 years ± 17 [standard deviation]) with the highest quality were selected for the reader study. Three observers blinded to the pathologic outcomes first described the B-mode image findings by using US Breast Imaging Reporting and Data System descriptors and derived a probability of malignancy. They then updated the probability by assessing strain images. Receiver operating characteristic (ROC …