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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07650656
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • High Grade Sarcoma
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Fluorescence Imaging — PROCEDURE
    Undergo fluorescence imaging
  • Fluorescence-Guided Surgery — PROCEDURE
    Undergo FGS
  • Indocyanine Green — DRUG
    Given IV
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Resection — PROCEDURE
    Undergo surgical resection

Study Details

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.

Key Dates

Start date
May 15, 2027
Status verified
Jun 2026
Primary completion
May 11, 2028
Completion
May 11, 2028

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (standard of care)
    Patients undergo standard of care surgical resection.
  • Experimental: Arm II (FGS)
    Patients receive ICG IV 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging.

Primary Outcome Measure

Unexpected positive margin (UPM) rate [ Time Frame: At 6 months post-surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Thinzar Lwin
[email protected]
626-218-3880
Thinzar Lwin (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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