Fluorescence-Guided Surgery Using Indocyanine Green to Improve Removal of Operable Intermediate-to-High Grade Sarcomas of the Extremities or Trunk

What this Trial Is About

Researchers are conducting a Danish national multicenter prospective cohort study to assess whether fluorescence-guided surgery FGS using indocyanine green ICG can decrease the rate of positive surgical margins in patients undergoing sarcoma removal. The study focuses on adults with biopsy-confirmed intermediate-to-high grade sarcoma of the extremities or trunk wall who are candidates for curative surgery. Participants will receive an intravenous dose of 1 mgkg of fluorescent ICG dye 2 to 24 hours before surgery. During the operation, a near-infrared SPY-PHI camera will guide the surgeon by detecting the fluorescent signal, helping to identify tumor margins more precisely. Areas showing fluorescence will be removed separately for pathological examination. This procedure is expected to add about 20 minutes to the surgery. Post-operative care will follow the current standard for sarcoma patients. Throughout the study, researchers will collect data on margin status from pathology reports and track whether participants require reoperation within 30 days due to positive margins. Additional information on reoperations for other reasons, positive margins without planned reoperation, and deaths will also be recorded. This new fluorescence-guided surgery group will be compared to a historic control group who received standard care. The overall participation period extends until the primary outcome assessment at 30 days post-surgery.

Fluorescence-Guided Optimization of Sarcoma Margins