5-AminoLevulinic Acid Aided Resection Margins in Sarcoma

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07038278
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Soft Tissue Sarcoma (STS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-ALA — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Intervention Group
    Patients diagnosed with Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) Grade 2 or 3 soft tissue sarcomas who undergo surgical resection will be administered 20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to anesthesia.

Primary Outcome Measure

Demonstrate the feasibility of 5-ALA aided fluorescent visualization of soft tissue sarcomas versus surrounding tissues [ Time Frame: From enrollment to 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Gregory Ottenberg
[email protected]
1-303-724-0875
Steven Thorpe, MD, FACS (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Hospital· Aurora, CO

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