Real-time Intraoperative Breast Cancer Visualization for Margin Assessment
Status:
Recruiting
Trial end date:
2025-02-28
Target enrollment:
Participant gender:
Summary
The investigators' preclinical data have demonstrated the feasibility of fluorescence-guided
tumor resection by Cancer Vision Goggles (CVG) with LS301 in animal models. In this study,
the investigators will conduct intraoperative imaging procedures that have minimal
interference with ongoing surgery. The underlying hypothesis is that the accurate detection
of all cancer cells highlighted by LS301 during surgery will reduce the number of breast
cancer patients with margin positivity to less than 5%, compared to the current surgical
paradigm of greater than 20%. The pilot study will obtain critical data required to address
the larger question of surgical margin assessment in a full Phase I clinical trial.