22 Participants NeededMy employer runs this trial

Fluorescence-Guided Surgery for Sarcoma

Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

TL

Thinzar Lwin

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for people of any age with a confirmed intermediate to high grade soft tissue sarcoma who are planning to have surgery to try and cure the cancer. Participants must be able to give consent, answer surveys, and allow review of their medical records. People with certain allergies, specific tumor locations, or those who are pregnant or breastfeeding cannot join.

Inclusion Criteria

Willingness to permit medical record/clinical laboratory result review
Documented written informed consent of the participant
Willingness to respond to surveys during the trial
See 3 more

Exclusion Criteria

Known allergies to ICG, iodine, iodine dyes or shellfish
I am scheduled for surgery to relieve symptoms, not to cure my condition.
My cancer is located in the brain, abdomen, or internal organs.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo either standard of care surgical resection or fluorescence-guided surgery with indocyanine green

During surgical resection
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Follow-up visits at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Fluorescence-Guided Surgery
  • Indocyanine Green

Trial Overview

The study compares standard surgery for sarcoma removal with a newer method that uses a special dye (indocyanine green) and fluorescent imaging during surgery. This helps surgeons better see the tumor edges in real time, aiming to reduce leftover cancer cells at the margins.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (FGS)Experimental Treatment5 Interventions
Group II: Arm I (standard of care)Active Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+