5-AminoLevulinic Acid Aided Resection Margins in Sarcoma
United States20 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Treatment decision includes planned surgical resection of STS.
✓. Age ≥18 years at time of consent.
✓. ECOG Performance Status 0 - 1.
✓. Hematology and blood chemistry parameters defined by:
✓. Leukocytes ≥ 3 × 10(9)/L
✓. Absolute neutrophil count ≥ 1.5 × 10(9)/L
✓. Platelets ≥ 100 × 109/L, transfusions may be used to raise platelets to ≥ 100 × 10(9)/L (no washout required)
Exclusion criteria
✕. Acute/chronic forms of porphyria.
✕. 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.
What they're measuring
1
Demonstrate the feasibility of 5-ALA aided fluorescent visualization of soft tissue sarcomas versus surrounding tissues
Timeframe: From enrollment to 2 weeks
2
Surgeon survey results of intraoperative tumor fluorescence
✕. Patient has had chemotherapy, tumor resection, or radiation treatment ≤ 21 days prior to surgery.
✕. Simultaneous participation in another clinical trial ≤ 21 days of enrollment or during the duration of the study period.
✕. 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).
✕. Pregnant or planning to become pregnant during study participation or breastfeeding.
✕. 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.