Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)

Conditions
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Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial

Intervention / Treatment
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* Drug: 18F-Fluciclovine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LGG (WHO grade I-II), confirmed by biopsy unless in Neurofibromatosis type 1 (NF1) participants with classic appearance Participants must have evaluable disease (1x1 cm tumor on MRI; enhancing + non-enhancing tumor) Scheduled to receive systemic therapy Performance Score: Karnofsky ≥ 50 for participants > 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. Age between ≥ 1 years but ≤21 years at time of study registration Exclusion Criteria: Inability to tolerate imaging procedures in the opinion of an investigator or treating physician Pregnant participants Patient who would require sedation or anesthesia for imaging beyond standard of care (SOC). Participants who weigh less than 8 kg. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection. Participants with a history of abnormal kidney function or creatinine above expected values for age and gender. Participants with primary tumors of the spinal cord.

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<br>18F-Fluciclovine PET-MRI | Drug: 18F-Fluciclovine<br>* 18F-Fluciclovine will be injected via IV prior to PET-MRI imaging<br>* Other names: Axumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare change in standardized uptake value parameters (SUVmax and SUVpeak) on metabolic tumor volume in 18F-Fluciclovine PET | To identify change in the standardized uptake value (SUV) parameters (SUVmax, SUVpeak) for the 18F-Fluciclovine PET scan | 1 year | 
| Compare changes in pretreatment tumor measurement on MRI in pediatric participants who initiate systemic treatment for LGG | Calculate the change in tumor measurement on MRI | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of 18F-Fluciclovine | The Safety profile of 18F-Fluciclovine PET in pediatric LGG participants will be accessed by the CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine | 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial, 18F-Fluciclovine