A Study of Metabolic Agents Following Brain Radiation

Study Overview
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Brief Summary
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This research is being done to determine if CEST Magnetic Resonance Imaging and F-dopa PET are feasible techniques to detect metabolic differences between tumor and brain.

Official Title
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Pilot Imaging Study for CNS Metabolism

Conditions
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CNS Malignancy

Intervention / Treatment
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* Diagnostic Test: F-DOPA Positron Emission Tomography
* Diagnostic Test: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiographic evidence or histopathologic confirmation of CNS malignancy, with or without prior resection. Provide written informed consent for the current study. Willing to undergo at least one MRI (at most two) with proton and/or phosphorus magnetic resonance spectroscopy analysis. Exclusion Criteria: Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped. Cardiac pacemaker or artificial heart valve Metal plate, pin, or other metallic implant Intrauterine device, such as Copper-7 IUD Insulin or other drug pump Non-titanium aneurysm clips Previous gunshot wound Cochlear implant or other hearing device Employment history as a metalworker (had metal in eye) Permanent (tattoo) eye-liner For 18F-DOPA-PET specifically: Concurrent use of anti-dopaminergic medications or dopamine agonists

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Central Nervous System Malignant Tumor<br>Subjects may receive up to two CEST MRI's tests and/or up to two F-DOPA PET. The physician will determine which test is appropriate based on your tumor type, past treatment history and research question. Tests will be completed at initial baseline visit and at least one other MRI/PET after the initial baseline, up to a maximum of four scans. | Diagnostic Test: F-DOPA Positron Emission Tomography<br>* Imaging using a F-DOPA radioactive tracer to look at the head.<br>* Other names: F-DOPA-PET scan;Diagnostic Test: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging<br>* A noninvasive diagnostic test for measuring biochemical changes in the brain, especially the presence of tumors.<br>* Other names: CEST MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects in whom glutamate metabolite is detected and measurable. | Number of subjects in whom glutamate metabolite is detected and measurable via CEST MRI in tumor, brain, and/or the ventricular space. | Baseline | 
| Number of subjects in whom n-acetylaspartate (NAA) metabolite is detected and measurable. | Number of subjects in whom n-acetylaspartate (NAA) metabolite is detected and measurable via CEST MRI in tumor, brain, and/or the ventricular space. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required to perform the CEST MRI study and measure metabolites of interest | Total time expressed in minutes required to perform the CEST MRI study and measure metabolites of interest. | Duration of CEST MRI scan, approximately one to two hours. |