drugset / Trial / NCT06252727

Fluorescent Aided Resection and Evaluation of Soft Tissue Sarcomas (FLARES)

NCT06252727

NaSingle-groupOpen-labelTreatment

Summary

This will be a prospective pilot study that will evaluate 20 patients who were diagnosed with FNCLCC Grade 2 or 3 soft tissue sarcomas and will undergo surgical resection. Based upon the FDA label, successful protocols used for intraoperative fluorescence-guided visualization for glioma resections, and on drug company current dosing recommendation for this study, patients will be administered 20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to surgery. The use of 5-ALA fluorescence will be relevant for evaluating the resected tumor per gross margins and identifying further areas of fluorescing tissues beyond the gross tumor margins.

Timeline

Start
2024-07
Primary completion
2026-02
Completion
2026-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Aminolevulinic Acid Diagnostic / imaging agent 20 mg/kg Oral

Indications