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Developing a New Metabolic Imaging Approach (aMRI) for Evaluating Neurological Disease in Patients With Gliomas

NCT ID: NCT05937776

Last Updated: 2025-11-10

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

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-11

Study Completion Date

2025-12-31

Brief Summary

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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

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PRIMARY OBJECTIVE:

I. 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:

I. 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:

I. 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

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Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Fludeoxyglucose F-18

Intervention Type OTHER

Given IV

Gadoterate Meglumine

Intervention Type OTHER

Given IV

Contrast-enhanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo PET/contrast-enhanced MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/contrast-enhanced MRI

Interventions

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Fludeoxyglucose F-18

Given IV

Intervention Type OTHER

Gadoterate Meglumine

Given IV

Intervention Type OTHER

Contrast-enhanced Magnetic Resonance Imaging

Undergo PET/contrast-enhanced MRI

Intervention Type PROCEDURE

Positron Emission Tomography

Undergo PET/contrast-enhanced MRI

Intervention Type PROCEDURE

Other Intervention Names

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¹⁸FDG 2-Deoxy-2-(18F)Fluoro-D-Glucose 2-F18-Fluoro-2-deoxy-D-glucose Fludeoxyglucose (18F) 105851-17-0 2-F18-Fluoro-2-deoxyglucose FDG fludeoxyglucose F 18 Fluorine-18 Fludeoxyglucose F18 2-Fluoro-2-deoxy-D-Glucose 92943-93-6 DOTAREM Gd-DOTA CONTRAST ENHANCED MRI Contrast-enhanced MRI MRI With Contrast Medical Imaging PET PET Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging PT

Eligibility Criteria

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Inclusion Criteria

* Adult patients (greater than 18 years of age) with glioma who require MRI and ¹⁸FDG-PET imaging.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Martin Pike, Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Pike, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Martin Pike, Ph.D.

Role: CONTACT

Phone: 503-494-2951

Email: [email protected]

Facility Contacts

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Martin Pike, Ph.D.

Role: primary

Other Identifiers

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NCI-2023-04867

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00024504

Identifier Type: -

Identifier Source: org_study_id