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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)

Conditions
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Glioma, High Grade Glioma, Glioma, Malignant, Glioma Intracranial, Diffuse Glioma

Intervention / Treatment
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* Drug: 18F-Fluciclovine PET-MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Histopathology-proven HGG (WHO grade III-IV) or DMG (WHO grade IV) or, in the case of DMG of the pons, imaging that is characteristic of Diffuse intrinsic pontine gliomas (DIPG) (diffusely infiltrating >=2/3 of the pons). 2. Measurable disease, measuring at least 1x1 cm. 3. Life expectancy of greater than 8 weeks. 4. Age > 1 years but < 21 years of age at enrollment. For those without planned surgery: 1. Participants with clinical and/or radiographic suspicion of True progression (TP) or Pseudoprogression (PsP) during radiation but yet to have the initial post-radiation MRI scan. or 2. Participants with suspicion for TP or PsP on first post-radiation MRI For those with planned surgery: 1. Clinical or radiographic suspicion of tumor progression with plan to undergo surgery or biopsy. Exclusion Criteria: 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician. 2. Pregnant or breastfeeding participants. 3. Participant who would require sedation or anesthesia for imaging beyond standard of care (SOC). 4. Participants who weigh less than 8 kg. 5. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection. 6. Participants with a history of abnormal kidney function or creatinine above expected values for age and gender.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants<br>Single intravenous administration of 18F fluciclovine for PET-MRI Scan | Drug: 18F-Fluciclovine PET-MRI<br>* 18F-Fluciclovine will be injected via IV prior to Positron emission tomography (PET)-Magnetic resonance imaging (MRI)<br>* Other names: Axumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image analysis | 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. | 6 months | 
| Histopathology analysis | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of 18F-Fluciclovine | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioma, High Grade Glioma, Glioma, Malignant, Glioma Intracranial, Diffuse Glioma, 18F fluciclovine