Testing a Glowing Medicine to Help Surgeons See Brain Tumors in Children
Official title: A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients
Status: Not yet recruiting. It has not opened yet. Ask your care team to watch for it if it looks like a fit.
The trial team last updated this record on .
The short version
This trial tests a medicine that makes brain tumors glow during surgery in children.
Read our full plain-language summary
What the trial team says
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.
Key facts
- Registry number
- NCT06907485
- Stage of testing
- Phase 2
- Conditions studied
- Pediatric Brain Tumor
Where it is running
This trial lists 2 sites.
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Illinois
- MidWest Children's Brain Tumor Center, Advocate Children's Hospital Park Ridge (Chicago)
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Pennsylvania
- UPMC Children's Hospital of Pittsburgh (Pittsburgh)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.