NCT06252727

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Demonstrate the feasibility of 5-ALA-aided fluorescent visualization of STS versus surrounding tissues. SECONDARY OBJECTIVE: I. Demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. II. Assess the safety profile of fluorescence-guided surgery (FGS) for STS utilizing 5-ALA. OUTLINE: Patients will be administered 20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to surgical resection. Intraoperative fluorescence-guided visualization will be used for evaluating the resected tumor per gross margins and identifying further areas of fluorescing tissues beyond the gross tumor margins.

Conditions

• Soft Tissue Sarcoma
• Soft Tissue Sarcoma Adult

Interventions

Type	Name	Description
DRUG	Aminolevulinic Acid	Given PO

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2024-02-12
• Last updated: 2024-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study