CNS MalignancyNCT06150547
A Study of Metabolic Agents Following Brain Radiation
An observational study of CNS Malignancy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Malignancy
- What is being tested?
- FDG Positron Emission Tomography and Chemical Exchange Saturation Transfer Magnetic Resonance Imaging
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2023to 4 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects identified as having a central nervous system malignant tumor undergoing routine care in the neuro-oncology practice at Mayo Clinic Rochester.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Imaging Study for CNS Metabolism
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
- Being tested
- FDG Positron Emission Tomography, Chemical Exchange Saturation Transfer Magnetic Resonance Imaging
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG Positron Emission TomographyDiagnostic test
Also called FDG PET scan, fludeoxyglucose-18 (FDG) positron emission tomography (PET)
Imaging using an FDG radioactive tracer to look at the head.
Chemical Exchange Saturation Transfer Magnetic Resonance ImagingDiagnostic test
Also called CEST MRI
A noninvasive diagnostic test for measuring biochemical changes in the brain, especially the presence of tumors.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: FDG Positron Emission Tomography; Diagnostic Test: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (1)
Time required to perform the CEST MRI study and measure metabolites of interest
Total time expressed in minutes required to perform the CEST MRI study and measure metabolites of interest.
Measured: Duration of CEST MRI scan, approximately one to two hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start27 Dec 2023
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS MalignancyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry C Burns, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150547
- Sponsor's protocol ID
- 22-009871
- Other IDs
- NCI-2024-03176
- Status last verified
- Aug 2025
- First submitted
- 21 Nov 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Imaging Study for CNS Metabolism
- ClinicalTrials.gov ID
- NCT06150547
- Acronym / sponsor ID
- 22-009871
- Conditions
- CNS Malignancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Central Nervous System Malignant Tumor | – | Diagnostic Test: FDG Positron Emission Tomography, Diagnostic Test: Chemical Exchange Saturation Transfer Magnetic Resonance ImagingSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects identified as having a central nervous system malignant tumor undergoing routine care in the neuro-oncology practice at Mayo Clinic Rochester.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG Positron Emission TomographyAlso: FDG PET scan, fludeoxyglucose-18 (FDG) positron emission tomography (PET)Imaging using an FDG radioactive tracer to look at the head. | Diagnostic test | Central Nervous System Malignant Tumor |
| Chemical Exchange Saturation Transfer Magnetic Resonance ImagingAlso: CEST MRIA noninvasive diagnostic test for measuring biochemical changes in the brain, especially the presence of tumors. | Diagnostic test | Central Nervous System Malignant Tumor |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry C Burns, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CNS Malignancy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects in whom glutamate metabolite is detected and measurable. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.