Recruiting
Phase 2

Fluorescence-Guided Resection

Sponsor:

City of Hope Medical Center

Code:

NCT07650656

Conditions

High Grade Sarcoma

Sarcoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Electronic Health Record Review

Fluorescence Imaging

Fluorescence-Guided Surgery

Indocyanine Green

Questionnaire Administration

Study Details

Brief 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.

Conditions

High Grade Sarcoma

Sarcoma

Study ID

NCT07650656

Start date

May 15, 2027

Status verified date

Jun, 2026

Completion date

May 11, 2028

Anticipated

Primary completion date

May 11, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Documented written informed consent of the participant
  • Histologically confirmed diagnosis of intermediate to high grade sarcoma
  • All ages
  • Amenable to surgical resection as a part of curative intent for the patient
  • Willingness to:

  • Respond to surveys during the trial
  • Permit medical record/ clinical laboratory result review

Exclusion Criteria:

  • Due for surgery with palliative intent
  • Recurrent tumors
  • Intracranial, retroperitoneal, and visceral anatomical locations
  • A woman of childbearing potential who is currently pregnant (as confirmed by urine pregnancy test)
  • A woman who are currently breastfeeding
  • Known allergies to ICG, iodine, iodine dyes or shellfish
  • Unable to provide written and informed consent
  • Patients with hyper-thyroidism or autonomic thyroid adenomas
  • Premature infants/neonates with exchange transfusion indication due to hyperbilirubinemia

Study Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Electronic Health Record Review

Ancillary studies

Fluorescence Imaging

Undergo fluorescence imaging

Fluorescence-Guided Surgery

Undergo FGS

Indocyanine Green

Given IV

Questionnaire Administration

Ancillary studies

Resection

Undergo surgical resection

Primary outcome measure

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

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

Thinzar Lwin

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-06-22.