Fluorescence-Guided Surgery for Sarcoma
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo either standard of care surgical resection or fluorescence-guided surgery with indocyanine green
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Patients receive ICG IV 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging.
Patients undergo standard of care surgical resection.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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