Real-time Intraoperative Breast Cancer Visualization for Margin Assessment

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. Phase 1: to determine the safety and optimal imaging dose of LS301 injected in breast cancer patients. Phase 2: to determine the ability of this novel fluorescence imaging agent to predict the presence of positive margins around partial mastectomy specimens and positive SLNs during surgical therapy for breast cancer.

Timeline

Start

2020-02-18

Primary completion

2022-01-27

Completion

2022-01-27

Outcome

Outcome not reported

Stopped (Enrollment): “Before LS301's licensing and reformulation, 9 patients received LS301-HSA (Phase 1a) , but since no patients were recruited (in Phase 1b) before the product expired, this study has been terminated.”

Drugs

Indications