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Completed

NCT Number: NCT05937776

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Treatment and study plan

Fludeoxyglucose F-18

Other

Given IV

Other names: 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

Gadoterate Meglumine

Other

Given IV

Other names: 92943-93-6, DOTAREM, Gd-DOTA

Contrast-enhanced Magnetic Resonance Imaging

Procedure

Undergo PET/contrast-enhanced MRI

Other names: CONTRAST ENHANCED MRI, Contrast-enhanced MRI, MRI With Contrast

Positron Emission Tomography

Procedure

Undergo PET/contrast-enhanced MRI

Other names: Medical Imaging, PET, PET Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean value of kᵢₒ*V in the tumor periphery and core regions

    Time frame: Up to 1 year

    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.

  2. kᵢₒ*V in different normal appearing brain sub-regions, unaffected by tumor

    Time frame: Up to 1 year

    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.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • Oregon Health and Science University

Registry information

Official study title

Development of Activity MRI (aMRI): Direct Comparison to PET in Human Subjects

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2023
Registry last updated
Jun 5, 2026

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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