Breast Cancer Detection and MR comparison Qualitative Analysis: We generated MRI sequences and SoftVue data for all 23 patients and compared the resulting images to determine the degree of concordance between them. We have found that the MRI and SoftVue images provide similar renderings of lesions and breast architecture, as illustrated in the figures below. The study concludes that SoftVue is capable of visualizing breast parenchyma, fibrous stroma, fatty tissues and lesions at a level of detail comparable to MRI. In addition, the threshold values for elevated sound speed and attenuation suggest the potential for more objective assessments even without intravenous contrast agents.
Comparison of MRI (left) and SoftVue (right) images shows a concordance of parenchyma (grey), fat (dark) and fibrous stroma (light grey).
Quantitative Analysis: Prior to better characterizing breast masses, we have been able to quantify the correlation of mammographic breast density with corresponding increases in local sound speed, measured by SoftVue. This also converts the evaluation from a two-dimensional image into a three-dimensional, more accurate assessment. We have also proven this improved 3-D correlation by comparison to percent breast parenchyma by MRI. Indeed, Figure 6 demonstrates the even higher correlation between MR signal intensity of benign parenchyma with the average sound speed by SoftVue (Pearson correlation coefficient of 0.92). Therefore, SoftVue has now demonstrated a 3-D, tissue-specific, MR signal intensity correlate of benign parenchyma, as well as a 2-D correlate of mammographic density (see Risk Assessment).
"SoftVue is currently under development and has not received clearance from the FDA at this time"