Fluorescence-guided surgery to reduce unexpected positive margins in high-grade sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized phase II study comparing two surgical approaches for sarcoma: standard resection versus fluorescence-guided resection using indocyanine green (ICG). Patients receive ICG 12–24 hours before surgery and undergo intraoperative fluorescence imaging in the experimental arm. The trial measures the rate of unexpected positive margins, with follow-up at 1, 3, 6, and 12 months to assess outcomes. Secondary and exploratory aims examine the broader effects of fluorescence guidance on margin assessment and underlying cellular mechanisms. The study is conducted at City of Hope Medical Center with NCI collaboration and includes adults with intermediate to high-grade sarcoma eligible for curative surgical resection.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting

Study contacts

• Principal investigator: Thinzar Lwin — City of Hope Medical Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MIGHTY: CAR T cells targeting B7-H3 for pediatric, teen, and young adult sarcoma

  This Phase 1 trial tests autologous hBRCA84D CAR T cells in kids, teens, and young adults (1–24) with relapsed or refractory RMS, ES, or DSRCT to see if the therapy is feasible and safe.

  Recruiting at 2 sites Phase 1 University College, London · London and 1 other locations · NCT07751380

• Lifileucel (Tumor-infiltrating lymphocytes) for advanced soft tissue sarcoma

  This study tests lifileucel, a cell therapy made from a patient’s own tumor cells, in adults with unresectable or metastatic soft tissue sarcoma who have had prior treatments to see if it helps shrink tumors and improve outcomes.

  Recruiting at 2 sites Phase 2 Iovance Biotherapeutics, Inc. · Tampa, Florida and 1 other locations · NCT07741877

• Domatinostat with Sirolimus for relapsed or refractory sarcoma and osteosarcoma

  This study tests whether the cancer drugs domatinostat and sirolimus together can help adolescents and adults whose sarcoma or osteosarcoma has come back or stopped responding to standard therapy.

  Recruiting at 2 sites Phase 1/2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida and 3 other locations · NCT07725380

• Clonal Hematopoiesis Effects with Chemo and Radiation in Solid Cancers

  This study tests whether clonal hematopoiesis affects outcomes for adults with solid cancers who are receiving chemotherapy or radiation.

  Recruiting Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07675967

• AYA Sarcoma Survivors: Personalized Exercise Program Pilot

  This pilot tests a personalized 12-week exercise program for adolescents and young adults with sarcoma to see if a triage tool can connect them with the right rehabilitation and exercise services.

  Recruiting at 3 sites Dana-Farber Cancer Institute · Boston, Massachusetts and 2 other locations · NCT07662239

• Hypnosis to help adolescents and young adults cope with cancer and chemotherapy

  This study tests whether hypnosis can reduce anxiety and chemotherapy-related symptoms in young people with sarcoma, germ cell tumors, or breast cancer.

  Recruiting Institut Bergonié · Bordeaux · NCT07614620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.