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NOT YET RECRUITING
NCT06907485
PHASE2

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

Sponsor: Costas Hadjipanayis

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-08

Completion Date

2028-08

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

DRUG

Aminolevulinic acid hydrochloride

Pediatric patients diagnosed with a new or recurrent brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal will receive aminolevulinic acid hydrochloride prior to surgery for resection of the brain tumor.

Locations (2)

MidWest Children's Brain Tumor Center, Advocate Children's Hospital Park Ridge

Chicago, Illinois, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States