This white paper presents a prospective clinical study evaluating the diagnostic performance of breast ultrasound using S-Shearwave Imaging™ on the RS85 Prestige ultrasound system in differentiating benign from malignant breast masses. The study was conducted at two institutions—Policlinico Universitario P. Giaccone (Italy) and Severance Hospital (Korea)—and included 591 focal breast lesions (FBLs) from 550 women between September 2020 and November 2022.
Each patient underwent grayscale breast ultrasound followed by shear wave elastography assessment using S-Shearwave Imaging™ on the RS85 Prestige system. Quantitative elasticity values—including Emax, Emean, Emin, and elasticity ratio (Eratio)—were measured to evaluate tissue stiffness and determine cut-off values for malignancy prediction.
The results showed that all elasticity parameters were significantly higher in malignant lesions (p < 0.001), with Emean and Emax demonstrating the highest diagnostic performance (AUCs: 0.802 and 0.794). Recommended cut-off values were 69.9 kPa for Emean and 82.3 kPa for Emax. Using these thresholds, breast ultrasound with S-Shearwave Imaging™ achieved 80% accuracy in distinguishing benign from malignant lesions.
The study concludes that vendor-specific elasticity parameters derived from RS85 Prestige can enhance diagnostic confidence in routine breast ultrasound examinations. The integration of S-Shearwave Imaging™ provides reliable, non-invasive assessment of breast lesion stiffness and supports more informed biopsy decisions.
For additional insights, refer to the related white paper on the application of S-Shearwave Imaging™ for diagnosis of breast mass using ultrasound elastography .
