A Study of Metabolic Agents Following Brain Radiation

November 21, 2023 updated by: Terry Burns, Mayo Clinic

Pilot Imaging Study for CNS Metabolism

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55906
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects in whom glutamate metabolite is detected and measurable.
Time Frame: Baseline
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.
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required to perform the CEST MRI study and measure metabolites of interest
Time Frame: 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.
Duration of CEST MRI scan, approximately one to two hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-009871

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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