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NOT YET RECRUITING
NCT07650656
PHASE2

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: SarcoSIGHT: A Randomized-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2027-05-15

Completion Date

2028-05-11

Last Updated

2026-06-16

Healthy Volunteers

No

Interventions

OTHER

Electronic Health Record Review

Ancillary studies

PROCEDURE

Fluorescence Imaging

Undergo fluorescence imaging

PROCEDURE

Fluorescence-Guided Surgery

Undergo FGS

DRUG

Indocyanine Green

Given IV

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Resection

Undergo surgical resection

Locations (1)

City of Hope Medical Center

Duarte, California, United States