What this study is
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.
What's being tested
- Electronic Health Record Review
Intervention · OTHER
- Fluorescence Imaging
Intervention · PROCEDURE
Undergo fluorescence imaging
- Fluorescence-Guided Surgery
Intervention · PROCEDURE
Undergo FGS
- Indocyanine Green
Intervention · DRUG
Given IV
- Questionnaire Administration
Intervention · OTHER
- Resection
Intervention · PROCEDURE
Undergo surgical resection
Both Electronic Health Record Review and Questionnaire Administration
Ancillary studies
Study details
- Official title
- SarcoSIGHT: A Randomized-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care
- Sponsor
- City of Hope Medical Center
- Conditions
- High Grade Sarcoma · Sarcoma
- Enrolling
- 22 people
- Starts
- 2026-08-14
- Est. completion
- 2029-12-17
- Design
- Single-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openCity of Hope Medical Center
Duarte, California, United States
- Thinzar Lwin · Contact626-218-3880tlwin@coh.org
- Thinzar Lwin · Principal investigator
Recruiting
Study team
Sponsor
City of Hope Medical Center
Study ID 24374
Principal investigator
Thinzar Lwin
City of Hope Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.