Phase 2Not yet recruiting
A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients
A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration
- Sponsor
- Costas Hadjipanayis (Academic or other)
- Enrollment
- 20 planned
- Conditions
- Pediatric Brain Tumor
- Interventions
- Aminolevulinic acid hydrochloride
- Ages
- children
- Registry
- NCT06907485
Full record on ClinicalTrials.gov
From the registry
This clinical trial focuses on pediatric patients aged 2 up to 18 years of age with a new or recurrent pediatric brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal. 5-aminolevulinic acid (5-ALA) is FDA-approved for improving brain tumor visualization in adults during surgery through fluorescence, enabling more complete removal of the tumor. This study aims to evaluate the feasibility of administering 5-ALA to pediatric brain tumor patients and to assess the quality of tumor fluorescence during surgery in this patient population. For the clinical trial, the patient will orally ingest 5-ALA 6 to 12 hours before brain surgery. All study participants will be provided standard medical care for removal of the brain tumor. All children enrolled in the study will be closely monitored prior to, during, and after surgery to ensure there are no reactions to the study drug. 5-ALA can make the patient more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. It is for this…
Primary outcomes
- Overall frequency/rate of positive fluorescence in all patients that receive 5-ALA
History
Study completion expected
Primary completion expected
Expected to start
Last registry update
Registered