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A Study of Metabolic Agents Following Brain Radiation

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06150547
Collaborator
(none)
10
Enrollment
1
Location
60.6
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: F-DOPA Positron Emission Tomography
  • Diagnostic Test: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pilot Imaging Study for CNS Metabolism
Actual Study Start Date :
Nov 14, 2023
Anticipated Primary Completion Date :
Dec 1, 2028
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Central Nervous System Malignant Tumor

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
Imaging using a F-DOPA radioactive tracer to look at the head.
Other Names:
  • F-DOPA-PET scan

    • Diagnostic Test: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging
    A noninvasive diagnostic test for measuring biochemical changes in the brain, especially the presence of tumors.
    Other Names:
  • CEST MRI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55906

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Terry C Burns, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Terry Burns, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT06150547
    Other Study ID Numbers:
    • 22-009871
    First Posted:
    Nov 29, 2023
    Last Update Posted:
    Nov 29, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Central Nervous System Neoplasms
    Dihydroxyphenylalanine

    Study Results

    No Results Posted as of Nov 29, 2023