A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients

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 reason that patients will be kept in subdued light conditions for 48 hours following surgery. Study participation starts once the patient is enrolled in the study until 6-month post-surgery.

NCT Number	NCT06907485
Lead Sponsor	Costas Hadjipanayis Collaborators: NX Development Corp, Southeastern Brain Tumor Foundation, StacheStrong Foundation, Neuroscience Research Foundation, University of Pittsburgh Medical Center, Advocate Hospital System
Conditions	Pediatric Brain Tumor
Enrollment	20 participants
Start Date	2026-08
Primary Completion	2028-02 (estimated)
Study Completion	2028-08 (estimated)
Updated on ClinicalTrials.gov	2026-01-21