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OpenTrials
Completed

NCT Number: NCT06150547

A Study of Metabolic Agents Following Brain Radiation

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.

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Key information

Conditions

CNS Malignancy Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FDG Positron Emission Tomography

Diagnostic Test

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

Other names: FDG PET scan, fludeoxyglucose-18 (FDG) positron emission tomography (PET)

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.

Other names: CEST MRI

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Pilot Imaging Study for CNS Metabolism

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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