Real-time Intraoperative Breast Cancer Visualization for Margin Assessment

• Status: Recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

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: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine

Criteria

Inclusion Criteria:

• Newly diagnosed Stage I-II breast cancer patients undergoing breast-conserving therapy and SLN biopsy.

• Negative nodal basin clinical exam.

• At least 18 years of age.

• Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

• Contraindications for surgery.

• Receiving any investigational agents.

• History of allergic reactions attributed to ICG or other agents used in the study, include known iodide or seafood allergy. The investigators do not expect many of these adverse reactions with LS301 because it is not radioactive and does not possess iodinated counter ions.

• Presence of underlying lung disease

• Pregnant. Female patients of childbearing potential must have a negative serum or urine pregnancy test no more than 7 days before start of participation.

• Breastfeeding. Patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LS301.