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Recruiting Not applicable

Fluorescence-Guided Optimization of Sarcoma Margins

NCT07134192 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2025-09-01
Last updated
2026-07-01

Condition(s) studied

Soft Tissue Sarcoma of the Trunk and ExtremitiesSarcoma

Investigational drug(s) / intervention(s)

Fluorescent-guided Surgery

Fluorescent-guided Surgery: Surgical treatment of the patient group will include the administration of a fluorescent dye and intraoperatively the resection will be aided and guided by the fluorescent signal. The wound bed will be inspected, areas with fluorescent signal will be excised and obtained separately for histopathology. Patients will receive the current post-operative standard of care for sarcoma patients

Study summary

This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Reresection — 30 days
    Reresection within 30 days will be used as primary endpoint as a proxy for histopathologically positive margin status following surgery which would require reoperation.

Trial sites (2)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus N Denmark Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07134192 on ClinicalTrials.gov ↗ ← All trials in Denmark