drugset / Trial / NCT06252727
Fluorescent Aided Resection and Evaluation of Soft Tissue Sarcomas (FLARES)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 20 mg/kg | Oral |