A Study of Metabolic Agents Following Brain Radiation

NCT ID: NCT06150547

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-27

Study Completion Date

2025-08-04

Brief Summary

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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

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Conditions

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CNS Malignancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

FDG Positron Emission Tomography

Intervention Type DIAGNOSTIC_TEST

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

Chemical Exchange Saturation Transfer Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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FDG Positron Emission Tomography

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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FDG PET scan fludeoxyglucose-18 (FDG) positron emission tomography (PET) CEST MRI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terry C Burns, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2024-03176

Identifier Type: OTHER

Identifier Source: secondary_id

22-009871

Identifier Type: -

Identifier Source: org_study_id

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