Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG
NCT05555550 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-29
Summary
The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.
Conditions
- Glioma
- Low-grade Glioma
- Low Grade Glioma of Brain
- Glioma, Malignant
- Glioma Intracranial
Interventions
- DRUG
-
18F-Fluciclovine
18F-Fluciclovine will be injected via IV prior to PET-MRI imaging
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 · The 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
- 2026-07-29
- Primary Completion
- 2026-12-31
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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