A Study of Metabolic Agents Following Brain Radiation

• Conditions: CNS Malignancy
• Interventions: Diagnostic Test: F-DOPA Positron Emission Tomography; Diagnostic Test: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging

• Registration Number: NCT06150547
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is being done to determine if CEST magnetic resonance imaging (MRI) and FDG PET are feasible techniques to detect metabolic differences between tumor and brain in patients with a brain tumor.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-14
• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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 (and possibly more at PI discretion) with proton and/or phosphorus magnetic resonance spectroscopy analysis.

Exclusion Criteria

• Vulnerable populations: pregnant or nursing women (Arm B exempt), 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 FDG-PET specifically: Fasting blood sugar level greater than 200mg/dl

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Central Nervous System Malignant Tumor	F-DOPA Positron Emission Tomography	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.
Central Nervous System Malignant Tumor	Chemical Exchange Saturation Transfer Magnetic Resonance Imaging	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time required to perform the CEST MRI study and measure metabolites of interest	Duration of CEST MRI scan, approximately one to two hours.	Total time expressed in minutes required to perform the CEST MRI study and measure metabolites of interest.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States