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

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.

Study Overview

• Status: Recruiting
• Conditions: Glioma
• Intervention / Treatment: Other: Fludeoxyglucose F-18; Other: Gadoterate Meglumine; Procedure: Contrast-enhanced Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Pike, Ph.D.; Phone Number: 503-494-2951; Email: pikema@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • OHSU Knight Cancer Institute
      • Contact: Martin Pike, Ph.D.; Phone Number: 503-494-2951; Email: pikema@ohsu.edu
      • Principal Investigator: Martin Pike, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with glioma

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Fludeoxyglucose F-18; Given IV; Other Names: FDG; fludeoxyglucose F 18; Fludeoxyglucose (18F); Fludeoxyglucose F18; 2-Deoxy-2-(18F)Fluoro-D-Glucose; 2-F18-Fluoro-2-deoxy-D-glucose; 2-F18-Fluoro-2-deoxyglucose; Fluorine-18; 105851-17-0; ¹⁸FDG; 2-Fluoro-2-deoxy-D-Glucose; Other: Gadoterate Meglumine; Given IV; Other Names: DOTAREM; Gd-DOTA; 92943-93-6; Procedure: Contrast-enhanced Magnetic Resonance Imaging; Undergo PET/contrast-enhanced MRI; Other Names: CONTRAST ENHANCED MRI; Contrast-enhanced MRI; MRI With Contrast; Procedure: Positron Emission Tomography; Undergo PET/contrast-enhanced MRI; Other Names: PET; PET Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; PT; Medical Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 1 year

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Martin Pike, Ph.D., OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma; Investigative Techniques; Pharmacologic Actions; Chemical Actions and Uses; Carbohydrates; Physical Phenomena; Specialty Uses of Chemicals; Chemistry Techniques, Analytical; Spectrum Analysis; Electromagnetic Phenomena; Magnetic Phenomena; Deoxyglucose; Deoxy Sugars; Electromagnetic Radiation; Radiation; Radiation, Ionizing; Diagnostic Uses of Chemicals; Fluorodeoxyglucose F18; Magnetic Resonance Spectroscopy; X-Rays; Contrast Media; Fluorine-18; gadoterate meglumine; gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
• Other Study ID Numbers: STUDY00024504; NCI-2023-04867 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No