Breast imaging with SoftVue: initial clinical evaluation

We describe the clinical performance of SoftVue, a breast imaging device based on the principles of ultrasound tomography. Participants were enrolled in an IRB-approved study at Wayne State University, Detroit, MI. The main research findings indicate that SoftVue is able to image the whole uncompressed breast up to cup size H. Masses can be imaged in even the densest breasts with the ability to discern margins and mass shapes. Additionally, it is demonstrated that multi-focal disease can also be imaged. The system was also tested in its research mode for additional imaging capabilities. These tests demonstrated the potential for generating tissue stiffness information for the entire breast using through-transmission data. This research capability differentiates SoftVue from the other whole breast systems on the market. It is also shown that MRI-like images can be generated using alternative processing of the echo data. Ongoing research is focused on validating and quantifying these findings in a larger sample of study participants and quantifying SoftVue's ability to differentiate benign masses from cancer.