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

Study Overview
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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.

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

Conditions
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Glioma

Intervention / Treatment
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* Other: Fludeoxyglucose F-18
* Other: Gadoterate Meglumine
* Procedure: Contrast-enhanced Magnetic Resonance Imaging
* Procedure: Positron Emission Tomography


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic (¹⁸FDG PET, MRI)<br>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<br>* Given IV<br>* Other names: 2-Fluoro-2-deoxy-D-Glucose;Other: Gadoterate Meglumine<br>* Given IV<br>* Other names: Gd-DOTA;Procedure: Contrast-enhanced Magnetic Resonance Imaging<br>* Undergo PET/contrast-enhanced MRI<br>* Other names: MRI With Contrast;Procedure: Positron Emission Tomography<br>* Undergo PET/contrast-enhanced MRI<br>* Other names: PT;|

What is the study measuring?
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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 |