18F-Fluciclovine PET-MRI in High-grade Glioma
NCT05553041 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-12-04
Summary
The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas. Investigators seek to determine if this imaging will help doctors tell the difference between tumor growth (progression) and other tumor changes that can occur after treatment.
Conditions
- Glioma
- High Grade Glioma
- Glioma, Malignant
- Glioma Intracranial
- Diffuse Glioma
Interventions
- DRUG
-
18F-Fluciclovine PET-MRI
18F-Fluciclovine will be injected via IV prior to Positron emission tomography (PET)-Magnetic resonance imaging (MRI)
Sponsors & Collaborators
-
Blue Earth Diagnostics
collaborator INDUSTRY -
Dragon Master Foundation
collaborator UNKNOWN -
Children's Hospital of Philadelphia
lead OTHER
Principal Investigators
-
Mariam Aboian, MD,PhD · children's hospital of philadelphia
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-07
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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