Fluorescence-guided surgery to optimize sarcoma margins
Official title: Fluorescence-Guided Optimization of Sarcoma Margins
Run by University of Aarhus · NCT07134192 · Data updated 2026-11-12
This will try using an injected fluorescent dye (ICG) during surgery to see if it reduces positive margins and reoperations for adults having curative surgery for intermediate-to-high grade soft tissue sarcoma of the trunk or limbs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus N and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | February 1, 2028 |
| Study ends | March 1, 2028 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT07134192 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age >18) with biopsy-verified intermediate-to-high grade operable soft tissue sarcoma of the trunk or extremities scheduled for curative-intent surgery, who can tolerate ICG and have adequate renal function, are ideal candidates.
✕Probably not a fit
Patients with inoperable disease, end-stage renal failure (eGFR <15), a known allergy to iodine-containing drugs, or those not undergoing curative-intent surgery are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Danish multicenter prospective cohort will give patients an intravenous bolus of 1 mg/kg indocyanine green (ICG) 16–24 hours before surgery and use the SPY-PHI system to visualize fluorescent tumor signal during resection. Surgeons will inspect the wound bed, excise areas showing fluorescence separately, and send those specimens for histopathology. The primary outcome is re-resection within 30 days because of positive margins on the initial resection, and tumor and margin data will be compared with a historic control cohort from the Danish Sarcoma Database. Patients must have biopsy-verified intermediate-to-high grade operable sarcoma of the extremity or trunk wall with curative intent and provide consent.
Why it matters
Potential benefit: If successful, using ICG-guided visualization could lower positive margin rates and reduce the need for additional surgeries, which may improve local control and spare patients extra procedures.
How similar studies have gone: Fluorescence-guided surgery with ICG has shown promise in other solid tumors and in small pilot sarcoma reports, but large controlled evidence specifically demonstrating reduced margin-positive rates in sarcoma is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biopsy verified intermediate-to-high grade sarcoma of theextremity or trunk wall * Age\>18 years old * Tumor operable * Curative intent at time of surgery * Consent of patient Exclusion Criteria: * History of allergic reaction to iodine-containing pharmaceuticals * End-stage renal disease or eGFR \<15 * Patient decision * Lack of capacity * Inoperability
Where it's running
-
Aarhus University Hospital
Aarhus N, Denmark Recruiting -
Rigshospitalet
Copenhagen, Denmark Recruiting
Study contacts
- Principal investigator: Thomas Baad-Hansen, MD, PhD — Orthopedic Surgical Department, Aarhus University Hospital
- Study coordinator: Christian Kveller, MD
- Email: chrkve@rm.dk
- Phone: +45 51 48 13 19
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.