NCT07038278

5-AminoLevulinic Acid Aided Resection Margins in Sarcoma

5-AminoLevulinic Acid Aided Resection Margins in Sarcoma (5-ALARMS)

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize the soft-tissue sarcoma (STS) during surgical resection. 5-ALA goes through the blood stream and into the tumor tissue allowing it to light up when the surgeon uses a special light in the operating room. The technique is called 5-ALA fluorescence-guided surgery (FGS). The main question aims to answer if 5-ALA provide intraoperative fluorescent visualization of soft-tissue sarcoma versus surrounding tissue and demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. Participants will be asked to orally administer 5-ALA three to four hours prior to surgery in preoperative area.

Conditions

• Soft Tissue Sarcoma (STS)

Interventions

Type	Name	Description
DRUG	5-ALA	5-ALA), also known by its brand name Gleolan, is an intermediate in the heme synthesis pathway that has been studied in tumor resections, especially in intracranial tumor resections. One advantage of intraoperative visualization with 5-ALA is the ability to directly visualize fluorescent tumor in the surgical field using a headset-mounted devices with fluorescence in the visual wavelength in real-time.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2025-06-26
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study