Study on Using Fluorescence-Guided Surgery to Reduce Unexpected Positive Margins in Sarcoma Patients

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT07650656

Provider View

This clinical trial is testing whether using a special dye and camera during surgery can help surgeons better remove sarcoma tumors, reducing the chance of leaving cancer cells behind.

Patient Parameters

Program Overview

This study is exploring a new surgical technique that uses a fluorescent dye called indocyanine green to help surgeons see and remove sarcoma tumors more effectively. The dye makes the tumor glow under a special camera, helping to distinguish cancerous tissue from healthy tissue. The goal is to reduce the number of cases where cancer cells are unexpectedly left behind after surgery, known as positive margins.

Description

The main goal of this study is to see if using fluorescence-guided surgery (FGS) with indocyanine green (ICG) can lower the rate of unexpected positive margins compared to standard surgery. Positive margins mean cancer cells are found at the edge of the removed tissue, indicating some cancer may be left behind.

Secondary goals include observing the effects of this technique over a year and understanding how the dye helps in assessing the removed tissue.

Participants will be randomly assigned to one of two groups:

  • Group 1: Undergo standard surgery without the dye.
  • Group 2: Receive the dye through an IV 12-24 hours before surgery and have surgery with the special camera.

After surgery, participants will have follow-up visits at 1, 3, 6, and 12 months to monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Have a confirmed diagnosis of intermediate to high-grade sarcoma.
  • Open to all ages.
  • Must be eligible for surgery aimed at curing the cancer.
  • Willing to answer surveys and allow access to medical records during the trial.

Exclusion Criteria

  • Scheduled for surgery that is not intended to cure the cancer.
  • Have tumors that have come back after previous treatment.
  • Tumors located in the brain, behind the abdomen, or in internal organs.
  • Women who are pregnant or breastfeeding.
  • Known allergies to the dye, iodine, or shellfish.
  • Unable to provide written consent.
  • Have certain thyroid conditions or are premature infants needing specific treatments.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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