This phase I/II trial tests the safety, best dose, and effectiveness of LS301 for detecting cancerous tissue when injected prior to surgery in patients with stage I-II breast cancer. LS301 is a substance that acts as a dye or an imaging agent. It accumulates in cancer-containing tissue and it fluoresces under near-infrared light, which allows the cancerous tissue to be visualized using special goggles. The use of LS301 may be effective in helping surgeons identify diseased tissue during surgery in patients with stage I-II breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT02807597.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine the safety and optimal imaging dose of fluorescent dye LS301 (LS301) injected in breast cancer patients. (Phase 1)
II. To determine the ability of this novel fluorescence imaging agent to predict the presence of positive margins around partial mastectomy specimens and positive sentinel lymph nodes (SLNs) during surgical therapy for breast cancer. (Phase 2)
OUTLINE: This is a phase I, dose-escalation study of LS301 followed by a phase II study.
Patients receive LS301 intravenously (IV) over 5-10 minutes and undergo intraoperative fluorescence imaging with Cancer Vision Goggles during standard of care (SOC) partial mastectomy and SLN biopsy 4-24 hours later. Patients also undergo blood sample collection on study.
Upon completion of study treatment, patients are followed up for 30 days post-surgery.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorDeborah E. Farr
