Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial

This phase II trial compares standard of care surgical resection to fluorescence-guided surgical resection using indocyanine green and fluorescence imaging for reducing unexpected positive margin rates in patients with sarcoma. Surgical margins are one of the criteria used in assessing the effectiveness of a given surgical procedure. They are the edges or border of the tissue removed in cancer surgery. A negative margin means that the resected tumor is surrounded by normal tissue, which implies there is no disease left in the patient. By contrast, a positive margin means that sarcoma cells are visible at the edge of the tumor. Positive margins may be classified as planned when they are expected pre-operatively due to the preservation of a critical structure, or unexpected when the pathologist reports the presence of tumor at the margin despite the surgeon having intended to remove it in its entirety. Fluorescence-guided surgery is an established surgical method that involves the administration of fluorescent dye (in this case, indocyanine green) into the tumor, which can then be visualized with a special camera during surgery to help surgeons identify tumor versus healthy tissue. Fluorescence-guided surgery may reduce the rate of unexpected positive margins in patients undergoing surgery for sarcoma.

NCT Number	NCT07650656
Lead Sponsor	City of Hope Medical Center Collaborators: National Cancer Institute (NCI)
Conditions	High Grade Sarcoma, Sarcoma
Enrollment	22 participants
Start Date	2027-05-15
Primary Completion	2028-05-11 (estimated)
Study Completion	2028-05-11 (estimated)
Updated on ClinicalTrials.gov	2026-06-22