Children's Hospital of Philadelphia
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.
Glioma
High Grade Glioma
Glioma, Malignant
Glioma Intracranial
Diffuse Glioma
18F-Fluciclovine PET-MRI
Early Phase 1
Following radiation and immunotherapy, many pediatric participants with high-grade gliomas (HGG), including diffuse midline glioma (DMG), demonstrate radiographic findings suspicious of disease progression. Differentiating post-treatment changes from true tumor progression is paramount to clinical decision-making, as true tumor progression may warrant a change in treatment, while post-treatment changes are typically not an indication to change treatment. Unfortunately, conventional MRI cannot reliably distinguish between true progression and post-treatment changes. Therefore, finding a physiological correlate to delineate true progression from pseudo-progression is critical. The overall objective of this current application is to evaluate 18F-fluciclovine PET imaging as a diagnostic biomarker for tumor progression compared to post-treatment changes in pediatric HGG. The long-term goal of this research is to accurately differentiate tumor progression from post-treatment changes in pediatric HGG using 18F-fluciclovine PET imaging.}}
Study Type : | Interventional |
Estimated Enrollment : | 30 participants |
Masking : | None (Open Label) |
Primary Purpose : | Diagnostic |
Official Title : | Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG) |
Actual Study Start Date : | August 7, 2023 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants Single intravenous administration of 18F fluciclovine for PET-MRI Scan |
Drug: 18F-Fluciclovine PET-MRI |
Ages Eligible for Study: | 1 Year to 21 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104