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

NCT06907485 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Pediatric Brain Tumor

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.

Sponsors & Collaborators

  • NX Development Corp

    collaborator INDUSTRY

  • Southeastern Brain Tumor Foundation

    collaborator UNKNOWN

  • StacheStrong Foundation

    collaborator UNKNOWN

  • Neuroscience Research Foundation

    collaborator UNKNOWN

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • Advocate Hospital System

    collaborator OTHER

  • Costas Hadjipanayis

    lead OTHER

Principal Investigators

  • Constantinos G. Hadjipanayis, MD, PhD · University of Pittsburgh

  • John Ruge, MD, FAANS · Midwest Children's Brain Tumor Center, Advocate Children's Hospital-Park Ridge

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-02-29
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06907485 on ClinicalTrials.gov