Clinical Trial

5-AminoLevulinic Acid Aided Resection Margins in Sarcoma

Study acronym: 5-ALARMS
Not Yet Recruiting Early Phase 1
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-06-17; most recent amendment 2026-07-21.
Trial Details
NCT Number NCT07038278
Lead Sponsor University of Colorado, Denver
Conditions Soft Tissue Sarcoma (STS)
Enrollment 20 participants
Start Date 2026-09-01
Primary Completion 2027-11-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-22