Envision radiologist Mary Hayes, M.D., recently began conducting a clinical research study to assess the effectiveness of a new imaging device designed to detect tumors in women with dense breasts. The study, sponsored by Real Imaging, utilizes the RI8 system to perform a compression-free mammogram in conjunction with a standard mammogram.

In women with dense breasts, tissue appears white on a standard mammogram, making it difficult to read mammographic images and detect tumors. As a result, cancerous tumors can be easily missed or hard to diagnose in the early stages, and early-stage detection is critical to a positive prognosis. The RI8 system aims to overcome these barriers by developing a comprehensive solution for risk assessment of breast cancer while maintaining a patient-friendly approach. The investigational device uses a robotic arm as the patient is scanned while sitting in a chair.

Dr. Hayes and the sub-investigators, Jessica Batista, M.D., and Rakesh Parbhu, M.D., are currently in phase 1 of the study called the Calibration Phase. During this phase, up to 300 women from each of the five participating centers – up to 1,500 women in total – are selected to develop a scan algorithm that will be applied during phase 2. The results from the scan will not be shared with volunteers or investigators during the first phase. Dr. Hayes’ team is the only non-academic participating center.

An additional 425 women with dense breast tissue will be enrolled for phase 2, and the scanning process will remain the same. The results of each participant’s traditional mammography and compression-free mammography will then dictate the next steps. If the imaging comes back positive for both scans, then the standard of care will remain the same as it would for a traditional mammography, and the woman will be treated accordingly. However, if a woman’s traditional mammography comes back negative but the compression-free scan comes back positive, the patient will be routed for further imaging funded by Real Imaging.

All women selected to participate in the study will be compensated for their time and travel. The research team will work closely with local hospitals to offer the study to women who qualify and will promote it through annual appointment reminders. The study is IRB-approved; therefore, there are no significant risks to the patient by enrolling.