A Study of Metabolic Agents Following Brain Radiation

NCT06150547 | Completed DMC

• 2 other identifiers: 22-009871NCI-2024-03176
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

CNS Malignancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Time required to perform the CEST MRI study and measure metabolites of interest

  Duration of CEST MRI scan, approximately one to two hours.

Study Arms (1)

Central Nervous System Malignant Tumor

Subjects may receive up to two CEST MRI's tests and/or up to two FDG 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. Additionally, patients undergo finger-poke blood collection prior to receiving FDG on study.

Diagnostic Test: FDG Positron Emission Tomography; Diagnostic Test: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging

Interventions

FDG Positron Emission Tomography DIAGNOSTIC_TEST

Imaging using an FDG radioactive tracer to look at the head.

Also known as: FDG PET scan, fludeoxyglucose-18 (FDG) positron emission tomography (PET)

Central Nervous System Malignant Tumor

Chemical Exchange Saturation Transfer Magnetic Resonance Imaging DIAGNOSTIC_TEST

A noninvasive diagnostic test for measuring biochemical changes in the brain, especially the presence of tumors.

Also known as: CEST MRI

Central Nervous System Malignant Tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects identified as having a central nervous system malignant tumor undergoing routine care in the neuro-oncology practice at Mayo Clinic Rochester.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55906, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Terry C Burns, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: December 27, 2023
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)