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

NCT05937776 | Recruiting

• 2 other identifiers: STUDY00024504NCI-2023-04867
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Up to 1 year

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

  Up to 1 year

Study Arms (1)

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; Other: Gadoterate Meglumine; Procedure: Contrast-enhanced Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Interventions

Fludeoxyglucose F-18 OTHER

Given IV

Also known as: 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

Diagnostic (¹⁸FDG PET, MRI)

Gadoterate Meglumine OTHER

Given IV

Also known as: 92943-93-6, DOTAREM, Gd-DOTA

Diagnostic (¹⁸FDG PET, MRI)

Contrast-enhanced Magnetic Resonance Imaging PROCEDURE

Undergo PET/contrast-enhanced MRI

Also known as: CONTRAST ENHANCED MRI, Contrast-enhanced MRI, MRI With Contrast

Diagnostic (¹⁸FDG PET, MRI)

Positron Emission Tomography PROCEDURE

Undergo PET/contrast-enhanced MRI

Also known as: Medical Imaging, PET, PET Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Diagnostic (¹⁸FDG PET, MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with glioma

You may qualify if:

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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Fluorodeoxyglucose F18; Fluorine-18; gadoterate meglumine; gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; Magnetic Resonance Spectroscopy; Contrast Media; X-Rays

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Martin Pike, Ph.D.

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Pike, Ph.D.

CONTACT

503-494-2951; pikema@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: December 11, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)