This white paper presents a prospective clinical study evaluating the diagnostic performance of S-Shearwave Imaging™, an ultrasound elastography technology integrated into the Samsung V8 ultrasound system, for the assessment of breast mass characteristics. Conducted at Gangnam Severance Hospital, the study involved 103 breast masses from 98 female patients examined between June 2021 and November 2022. Each mass was either pathologically confirmed or clinically stable over 24 months according to ACR BI-RADS® criteria.
The study aimed to differentiate benign from malignant breast masses by quantifying tissue stiffness using S-Shearwave Imaging™. Each lesion was examined with a linear LA2-14A probe in split-screen mode, displaying both gray-scale ultrasound and elasticity images. Elasticity values were measured through sub-regions of interest (sub-ROIs), and the system provided Emax, Emean, Emin, and Eratio.
Statistical analysis revealed that malignant breast masses exhibited significantly higher elasticity values than benign ones across all parameters (p < 0.001). The optimal cutoff values for differentiating malignancy were determined using ROC analysis: 82.3 kPa for Emax, 51.3 kPa for Emean, 42.9 kPa for Emin, and 4.0 for Eratio. Among these, Emean and Emax showed the highest diagnostic performance with an AUC of 0.903 and 0.903 respectively.
The findings suggest that S-Shearwave Imaging™ provides reliable quantitative data that complements conventional breast ultrasound, improving the specificity and diagnostic confidence in identifying malignant breast masses. The technique allows for real-time visualization and measurement of tissue stiffness, contributing to more informed clinical decision-making in breast imaging.
For additional insights, refer to the related white paper on the application of S-Shearwave Imaging™ on breast ultrasound .
