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High Grade SarcomaCancerProcedureDrugPhase 2

What this study is

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.

What's being tested

  • Electronic Health Record Review

    Intervention · OTHER

  • Fluorescence Imaging

    Intervention · PROCEDURE

    Undergo fluorescence imaging

  • Fluorescence-Guided Surgery

    Intervention · PROCEDURE

    Undergo FGS

  • Indocyanine Green

    Intervention · DRUG

    Given IV

  • Questionnaire Administration

    Intervention · OTHER

  • Resection

    Intervention · PROCEDURE

    Undergo surgical resection

Both Electronic Health Record Review and Questionnaire Administration

Ancillary studies

Study details

Official title
SarcoSIGHT: A Randomized-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care
Sponsor
City of Hope Medical Center
Conditions
High Grade Sarcoma · Sarcoma
Enrolling
22 people
Starts
2026-08-14
Est. completion
2029-12-17
Design
Single-blind, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗