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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Costas Hadjipanayis
Study ID
NCT06907485
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pediatric Brain Tumor

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Aminolevulinic acid hydrochloride — DRUG
    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.

Study Details

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 Dates

Start date
Aug 31, 2026
Status verified
Jan 2026
Primary completion
Feb 29, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Aminolevulinic acid hydrochloride
    Single arm study administering a single oral solution of aminolevulinic acid hydrochloride at a dose of 20 mg/kg body weight, 6-12 hours prior to brain surgery for resection of the tumor.

Primary Outcome Measure

Overall frequency/rate of positive fluorescence in all patients that receive 5-ALA [ Time Frame: Day of Surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MidWest Children's Brain Tumor Center, Advocate Children's Hospital Park RidgeChicagoIllinois60068
John Ruge, MD
[email protected]
847-723-6611
John Ruge, MD (PRINCIPAL_INVESTIGATOR)
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224
Swetha Thambireddy, MPH
[email protected]
412-692-9960
Cody Nesvick, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
MidWest Children's Brain Tumor Center, Advocate Children's Hospital Park Ridge· Chicago, ILUPMC Children's Hospital of Pittsburgh· Pittsburgh, PA

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