Glioma Clinical Trial - 18F-Fluciclovine PET-MRI in High-grade Glioma

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05553041
Study type	Interventional
Source	Children's Hospital of Philadelphia
Contact	Ali Nabavizadeh
Phone	215-590-1000
Email	nabavizadehs@chop.edu
Status	Recruiting
Phase	Early Phase 1
Start date	August 7, 2023
Completion date	December 2026

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