18F-Fluciclovine PET-MRI in High-grade Glioma
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|ClinicalTrials.gov Identifier: NCT05553041|
Recruitment Status : Not yet recruiting
First Posted : September 23, 2022
Last Update Posted : September 23, 2022
|Condition or disease||Intervention/treatment||Phase|
|Glioma High Grade Glioma Glioma, Malignant Glioma Intracranial Diffuse Glioma||Drug: 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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)|
|Estimated Study Start Date :||October 2022|
|Estimated Primary Completion Date :||October 2025|
|Estimated Study Completion Date :||October 2026|
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
18F-Fluciclovine will be injected via IV prior to Positron emission tomography (PET)-Magnetic resonance imaging (MRI)
Other Name: Axumin
- Image analysis [ Time Frame: 6 months ]Comparison of Standardized uptake value (SUV) max, SUV peak, and uptake kinetics post radiation between participants who experience true progression versus those who experience pseudoprogression as confirmed by routine imaging.
- Histopathology analysis [ Time Frame: 4 weeks ]Evaluation of SUV uptake post radiation in participants with planned biopsy or resection who experience true progression versus those who experience pseudoprogression as confirmed by histopathology.
- Safety of 18F-Fluciclovine [ Time Frame: 6 months ]The Safety profile of 18F-Fluciclovine PET in pediatric HGG participants will be assessed based on CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05553041
|Contact: Ali Nabavizadehemail@example.com|
|Contact: Hannah Andersonfirstname.lastname@example.org|
|Principal Investigator:||Ali Nabavizadeh, MD||Children's Hospital of Philadelphia|