Differentiating Benign from Malignant Solid Breast Masses with US

Purpose: To prospectively evaluate the sensitivity and specificity of ultrasonographic (US) strain imaging for distinguishing be-tween 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 Report-ing and Data System descriptors and derived a probability of malignancy. They then updated the probability by as-sessing strain images. Receiver operating characteristic (ROC) curves were constructed by using these probabili-ties. Areas under the ROC curve, sensitivities, and speci-ficities were calculated and compared. Interobserver vari-ability and the correlation between automated and subjec-tive image quality assessment were analyzed. Results: The average area under the ROC curve for all three read-ers after US strain imaging (0.903) was greater than that after B-mode US alone (0.876, P .014). With use of a 2% probability of malignancy threshold, strain imaging—as compared with B-mode US alone—had improved average specificity (0.257 vs 0.132, P .001) and high sensitivity (0.993 vs 0.987, P .99). Significant interobserver vari-ability was observed (P .001). The ability to assess strain image quality appeared to correlate with the highest ob-server performance. Conclusion: US strain imaging can facilitate improved classification of benign and malignant breast masses. However, interob-server variability and image quality influence observer per-formance