Fluorescence-Guided Optimization of Sarcoma Margins

Sponsor
University of Aarhus
Study ID
NCT07134192
Status
Recruiting
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Conditions

  • Sarcoma
  • Soft Tissue Sarcoma of the Trunk and Extremities

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluorescent-guided Surgery — PROCEDURE
    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 Details

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.

Key Dates

First listed
Aug 21, 2025
Start date
Sep 1, 2025
Status verified
Jul 2025
Primary completion
Feb 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fluorescence-guided surgery cohort
    Patients with intermediate-to-high grade sarcomas eligible for curative surgical treatment at time of surgery. Surgery will be augmented by guidance through the use of a near-infrared camera and fluorescent dye administered hours prior to surgery.

Primary Outcome Measure

Reresection [ Time Frame: 30 days ]

Central Contacts

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