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5-AminoLevulinic Acid Aided Resection Margins in Sarcoma

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

NCT07038278•University of Colorado, Denver

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histological confirmation of any subtype of primary Grades 2 or 3 soft tissue sarcomas (STS), per biopsy evaluation by a pathologist, according to Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC).
•2. Treatment decision includes planned surgical resection of STS.
•3. Age ≥18 years at time of consent.
•4. ECOG Performance Status 0 - 1.
•5. Hematology and blood chemistry parameters defined by:
•1. Leukocytes ≥ 3 × 10(9)/L
•2. Absolute neutrophil count ≥ 1.5 × 10(9)/L
•3. Platelets ≥ 100 × 109/L, transfusions may be used to raise platelets to ≥ 100 × 10(9)/L (no washout required)
•4. Hemoglobin ≥ 9 g/dL, transfusions may be used to raise Hgb to ≥ 9 g/dL (no washout required)
•5. Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
+7 more criteria

Exclusion Criteria

•1. Acute/chronic forms of porphyria.
•2. Uncontrolled, known concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
•3. Patient has had chemotherapy, tumor resection, or radiation treatment ≤ 21 days prior to surgery.
•4. Simultaneous participation in another clinical trial ≤ 21 days of enrollment or during the duration of the study period.
•5. Planned use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones and tetracyclines), and topical preparations containing aminolevulinic acid (5-ALA) for 24 hours during the perioperative period (defined as 24 hours prior to surgery to up to 24 hours post-surgery).
•6. Pregnant or planning to become pregnant during study participation or breastfeeding.
•7. Any condition that is in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial.

Locations (1)

University of Colorado Hospital

Aurora, Colorado, United States

Key Dates

Start Date

April 1, 2026

Primary Completion Date

November 1, 2027

Completion Date

November 1, 2028

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Soft Tissue Sarcoma (STS)

Interventions

5-ALA

DRUG

Contacts

Gregory Ottenberg

CONTACT

303-724-0875 gregory.ottenberg@cuanschutz.edu

Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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5-AminoLevulinic Acid Aided Resection Margins in Sarcoma

Inclusion Criteria

Exclusion Criteria

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