GliomaNCT05937776
Developing a New Metabolic Imaging Approach (aMRI) for Evaluating Neurological Disease in Patients With Gliomas
An observational study of Glioma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This is an observational study to compare the utility of the novel aMRI approach in human brain to the standard of care imaging approach for diagnosing and assessing glioma. Tumor cells have altered metabolism compared to normal cells.This makes metabolic activity imaging useful for diagnosing and assessing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Fludeoxyglucose F-18, Gadoterate Meglumine and Contrast-enhanced Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2023to 31 Dec 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: Adult patients with glioma
Who may be able to join
- Adult patients (greater than 18 years of age) with glioma who require MRI and ¹⁸FDG-PET imaging.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Development of Activity MRI (aMRI): Direct Comparison to PET in Human Subjects
This is an observational study to compare the utility of the novel aMRI approach in human brain to the standard of care imaging approach for diagnosing and assessing glioma. Tumor cells have altered metabolism compared to normal cells.This makes metabolic activity imaging useful for diagnosing and assessing neurological disease. However, current options for metabolic activity imaging are limited. Metabolic activity imaging is primarily conducted using positron emission tomography (PET) with a radioactive tracer called fludeoxyglucose F-18 (¹⁸FDG). A PET scan is a procedure in which a small amount of radioactive glucose (¹⁸FDG) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. PET imaging is very expensive and is usually much less available than other imaging techniques such as magnetic resonance imaging (MRI). MRI uses radiofrequency waves and a strong magnetic field to provide clear and detailed pictures of internal organs and tissues. While MRI is more available than PET, it isn't as useful in evaluating metabolic activity. Unlike standard MRI, the aMRI approach uses new ways of analyzing MRI images that provides information about tumor cell metabolic activity. Via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET, this clinical trial will assess the validity of aMRI as a metabolic imaging approach for evaluating neurological disease in patients with glioma.
Read the detailed description
PRIMARY OBJECTIVE:
- Characterize how the metabolic aMRI parameter kᵢₒ*V differs in tumor versus (vs) normal brain. Researchers will assess the validity of aMRI as a metabolic imaging approach via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET.
SECONDARY OBJECTIVES:
- Post-gadolinium (Gd) T1 MRI will be used to distinguish the contrast-enhancing "ring" region indicating the metabolically active tumor periphery from the less viable and/or necrotic tumor core. The utility of aMRI to differentially assess the metabolically active tumor periphery and necrotic core regions will be determined and compared to that of ¹⁸FDG PET (SUVmax).
II. Characterize how the metabolic aMRI parameter kᵢₒ*V differs in the various normal appearing brain sub-regions unaffected by tumor, in comparison to ¹⁸FDG PET.
EXPLORATORY OBJECTIVE:
- To compare how the aMRI metabolic parameter kᵢₒ*V within disease lesions change with different disease types, their disease stage, and their treatment status.
OUTLINE:
Patients receive ¹⁸FDG IV, then 60 minutes later undergo simultaneous MRI and PET scanning. During this scanning period, patients will receive gadoterate meglumine IV to obtain post-contrast MRI. Total scanning time will take 45-60 minutes.
- Conditions
- Glioma
- Being tested
- Fludeoxyglucose F-18, Gadoterate Meglumine, Contrast-enhanced Magnetic Resonance Imaging, Positron Emission Tomography
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludeoxyglucose F-18Other
Also called ¹⁸FDG, 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose, Fludeoxyglucose (18F)
Given IV
Gadoterate MeglumineOther
Also called 92943-93-6, DOTAREM, Gd-DOTA
Given IV
Contrast-enhanced Magnetic Resonance ImagingProcedure or surgery
Also called CONTRAST ENHANCED MRI, Contrast-enhanced MRI, MRI With Contrast
Undergo PET/contrast-enhanced MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, PET, PET Scan, Positron-Emission Tomography
Undergo PET/contrast-enhanced MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (¹⁸FDG PET, MRI) | Patients receive ¹⁸FDG IV, then 60 minutes later undergo simultaneous MRI and PET scanning. During this scanning period, patients will receive gadoterate meglumine IV to obtain post-contrast MRI. Total scanning time will take 45-60 minutes. Receives: Other: Fludeoxyglucose F-18; Other: Gadoterate Meglumine; Procedure: Contrast-enhanced Magnetic Resonance Imaging; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean values of kᵢₒ*V of the entire tumor region
In subjects with glioma brain tumors, outlines of tumor regions will be defined by post-contrast T1 magnetic resonance images. Mean values of kᵢₒ*V of the entire tumor region will be obtained and in normal-appearing contralateral regions for comparison. The profile of mean values in these regions will be evaluated for efficacy in metabolically distinguishing them, and evaluated for correlation with the co-registered flurodeoxyglucose F-18 (¹⁸FDG) positron emission tomography (PET) (standardized uptake value maximum [SUVmax]) data. The observation of robust correlation with PET, would validate activity magnetic resonance imaging (aMRI) as a metabolic sensor.
Measured: Up to 1 year
Secondary outcomes (2)
Mean value of kᵢₒ*V in the tumor periphery and core regions
Mean values of kᵢₒ*V will be obtained in the tumor periphery and core regions. The data will be evaluated for utility in metabolically distinguishing them, and evaluated for correlation with the co-registered ¹⁸FDG PET (SUVmax) data.
Measured: Up to 1 year
kᵢₒ*V in different normal appearing brain sub-regions, unaffected by tumor
Will quantify the aMRI metabolic parameter kᵢₒ*V in different normal appearing brain sub-regions, unaffected by tumor, as defined by registration to a human brain Atlas. The profile of mean values in these regions will be evaluated for efficacy in metabolically distinguishing them, and evaluated for correlation with the simultaneously obtained and co-registered ¹⁸FDG PET (SUVmax) data.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start11 Dec 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Martin Pike, Ph.D., OHSU Knight Cancer Institute
- Investigators
- Martin Pike, Ph.D., Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937776
- Sponsor's protocol ID
- STUDY00024504
- Other IDs
- NCI-2023-04867
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Activity MRI (aMRI): Direct Comparison to PET in Human Subjects
- ClinicalTrials.gov ID
- NCT05937776
- Acronym / sponsor ID
- STUDY00024504
- Conditions
- Glioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Jul 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 is an observational study to compare the utility of the novel aMRI approach in human brain to the standard of care imaging approach for diagnosing and assessing glioma. Tumor cells have altered metabolism compared to normal cells.This makes metabolic activity imaging useful for diagnosing and assessing neurological disease. However, current options for metabolic activity imaging are limited. Metabolic activity imaging is primarily conducted using positron emission tomography (PET) with a radioactive tracer called fludeoxyglucose F-18 (¹⁸FDG). A PET scan is a procedure in which a small amount of radioactive glucose (¹⁸FDG) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. PET imaging is very expensive and is usually much less available than other imaging techniques such as magnetic resonance imaging (MRI). MRI uses radiofrequency waves and a strong magnetic field to provide clear and detailed pictures of internal organs and tissues. While MRI is more available than PET, it isn't as useful in evaluating metabolic activity. Unlike standard MRI, the aMRI approach uses new ways of analyzing MRI images that provides information about tumor cell metabolic activity. Via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET, this clinical trial will assess the validity of aMRI as a metabolic imaging approach for evaluating neurological disease in patients with glioma.
Detailed description
PRIMARY OBJECTIVE:
- Characterize how the metabolic aMRI parameter kᵢₒ*V differs in tumor versus (vs) normal brain. Researchers will assess the validity of aMRI as a metabolic imaging approach via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET.
SECONDARY OBJECTIVES:
- Post-gadolinium (Gd) T1 MRI will be used to distinguish the contrast-enhancing "ring" region indicating the metabolically active tumor periphery from the less viable and/or necrotic tumor core. The utility of aMRI to differentially assess the metabolically active tumor periphery and necrotic core regions will be determined and compared to that of ¹⁸FDG PET (SUVmax).
II. Characterize how the metabolic aMRI parameter kᵢₒ*V differs in the various normal appearing brain sub-regions unaffected by tumor, in comparison to ¹⁸FDG PET.
EXPLORATORY OBJECTIVE:
- To compare how the aMRI metabolic parameter kᵢₒ*V within disease lesions change with different disease types, their disease stage, and their treatment status.
OUTLINE:
Patients receive ¹⁸FDG IV, then 60 minutes later undergo simultaneous MRI and PET scanning. During this scanning period, patients will receive gadoterate meglumine IV to obtain post-contrast MRI. Total scanning time will take 45-60 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (¹⁸FDG PET, MRI) | – | Other: Fludeoxyglucose F-18, Other: Gadoterate Meglumine, Procedure: Contrast-enhanced Magnetic Resonance Imaging, Procedure: Positron Emission TomographyPatients receive ¹⁸FDG IV, then 60 minutes later undergo simultaneous MRI and PET scanning. During this scanning period, patients will receive gadoterate meglumine IV to obtain post-contrast MRI. Total scanning time will take 45-60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with glioma
Key inclusion criteria (1 listed)
- Adult patients (greater than 18 years of age) with glioma who require MRI and ¹⁸FDG-PET imaging.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Fludeoxyglucose F-18Also: ¹⁸FDG, 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose, Fludeoxyglucose (18F)Given IV | Other | Diagnostic (¹⁸FDG PET, MRI) |
| Gadoterate MeglumineAlso: 92943-93-6, DOTAREM, Gd-DOTAGiven IV | Other | Diagnostic (¹⁸FDG PET, MRI) |
| Contrast-enhanced Magnetic Resonance ImagingAlso: CONTRAST ENHANCED MRI, Contrast-enhanced MRI, MRI With ContrastUndergo PET/contrast-enhanced MRI | Procedure or surgery | Diagnostic (¹⁸FDG PET, MRI) |
| Positron Emission TomographyAlso: Medical Imaging, PET, PET Scan, Positron-Emission TomographyUndergo PET/contrast-enhanced MRI | Procedure or surgery | Diagnostic (¹⁸FDG PET, MRI) |
Primary outcome
Mean values of kᵢₒ*V of the entire tumor region
Time frame: Up to 1 year
In subjects with glioma brain tumors, outlines of tumor regions will be defined by post-contrast T1 magnetic resonance images. Mean values of kᵢₒ*V of the entire tumor region will be obtained and in normal-appearing contralateral regions for comparison. The profile of mean values in these regions will be evaluated for efficacy in metabolically distinguishing them, and evaluated for correlation with the co-registered flurodeoxyglucose F-18 (¹⁸FDG) positron emission tomography (PET) (standardized uptake value maximum [SUVmax]) data. The observation of robust correlation with PET, would validate activity magnetic resonance imaging (aMRI) as a metabolic sensor.
2 secondary outcomes
Mean value of kᵢₒ*V in the tumor periphery and core regions
Time frame: Up to 1 year
kᵢₒ*V in different normal appearing brain sub-regions, unaffected by tumor
Time frame: Up to 1 year
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 5 Jun 2026.
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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.
Martin Pike, Ph.D. principal investigator
OHSU Knight Cancer Institute
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 Glioma, run by OHSU Knight Cancer Institute 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 1 inclusion and 0 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 5 Jun 2026. 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?
Mean values of kᵢₒ*V of the entire tumor region (time frame: Up to 1 year). 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 5 Jun 2026.