Status:
NOT_YET_RECRUITING
A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients
Lead Sponsor:
Costas Hadjipanayis
Collaborating Sponsors:
NX Development Corp
Southeastern Brain Tumor Foundation
Conditions:
Pediatric Brain Tumor
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief 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...
Detailed Description
The aim of this study is to assess the feasibility of administering 5-ALA pre-operatively and to access if the resulting 5-ALA-induced tumor fluorescence is adequate for fluorescence-guided brain tumo...
Eligibility Criteria
Inclusion
- Subjects included in this trial must have had an MRI documentation of "a new or recurrent primary pediatric brain tumor" for which resection is indicated and has been planned.
- The anticipated histology at resection will be "newly diagnosed" or "recurrent": pilocytic astrocytoma, pleomorphic xanthoastrocytoma (PXA), ganglioglioma, diffuse neuroepithelial tumor (DNET), astrocytoma, oligodendroglioma, ependymoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ependymoma, anaplastic ganglioglioma, anaplastic PXA, PNET, ATRT, or medulloblastoma.
- Male or Female Age 2-17 years and 182 days
- Subjects must have normal organ and marrow function as defined below:
- Leukocytes \>3,000/mL Platelets \>100,000/mL Total bilirubin Below upper limit of normal (ULN) AST (SGOT)/ALT (SGPT)/ GGT \<2.5 X institutional age-specific ULN Creatinine Below ULN
- OR
- Creatinine Clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional age-specific normal as defined per institution.
- The effects of 5-ALA on the developing human fetus are unknown. A pregnancy test will be performed for all young women of childbearing ability prior to surgery (see Exclusion Criteria below). Should a young woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability for patient/patient's guardian to understand and the willingness to sign a written informed consent document. In appropriate cases, assent of pediatric patients will be obtained. Translation will be provided as appropriate.
- Inclusion of Women and Minorities: Both males and females and members of all ethnic groups are eligible for this trial.
Exclusion
- Patients who meet inclusion criteria but are unable to swallow 5-ALA solution.
- Patients with radiographic tumors of the brain stem as assessed by MRI.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-ALA. Patients should refrain from use of other potential phototoxic substances (e.g., tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) for 24 h.
- Personal or family history of porphyria.
- Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, heart disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-ALA breastfeeding should be discontinued if the mother is treated 5-ALA.
- Young women who are pregnant or become pregnant will be excluded from the trial as it is unknown if 5-ALA is teratogenic or has abortifacient effects. A pregnancy test will be performed on all young women who are s/p menstruation prior to entering study.
- Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06907485
Start Date
December 1 2025
End Date
December 1 2027
Last Update
July 17 2025
Active Locations (2)
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1
MidWest Children's Brain Tumor Center, Advocate Children's Hospital Park Ridge
Chicago, Illinois, United States, 60068
2
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224