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

Primary Purpose

Glioma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fludeoxyglucose F-18
Gadoterate Meglumine
Contrast-enhanced Magnetic Resonance Imaging
Positron Emission Tomography
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients (greater than 18 years of age) with glioma who require MRI and ¹⁸FDG-PET imaging. Exclusion Criteria: Pregnant or breastfeeding. Adults lacking capacity to consent not will be included in this study. All other vulnerable populations - children, pregnant women, and prisoners - will not be included. Contraindication to PET, MRI, ¹⁸FDG or intravenous gadolinium-based contrast agents. Claustrophobia. Weight greater than modality maximum capacity. Presence of metallic foreign body or implanted medical devices in body not documented as MRI safe according to the OHSU Department of Radiology Guidelines (including but not limited to cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants). Sickle cell disease. Reduced renal function, as determined by GFR < 45 mL/min/1.73 m2 based on a serum creatinine level obtained per OHSU Department of Radiology and OHSU Advanced Imaging Research Center (AIRC) clinical criteria. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ¹⁸FDG. Unsure of pregnancy status as assessed by Department of Radiology and AIRC guidelines. Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject. Poor peripheral intravenous access evaluated by patient history. Presence of other serious systemic illnesses, including: uncontrolled infection, other uncontrolled malignancy, uncontrolled diabetes type II, or psychiatric/social situations which might impact the endpoint of the study or limit compliance with study requirements.

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (¹⁸FDG PET, contrast-enhanced MRI)

Arm Description

Patients receive ¹⁸FDG IV then 30 minutes later, receive gadoterate meglumine IV and undergo PET/contrast-enhanced MRI over 20 to 40 minutes on study.

Outcomes

Primary Outcome Measures

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 fludeoxyglucose 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 Outcome Measures

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.
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. In future studies with a modified protocol, healthy controls maybe be utilized to further extend these studies.

Full Information

First Posted
June 30, 2023
Last Updated
September 29, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT05937776
Brief Title
Developing a New Metabolic Imaging Approach (aMRI) for Evaluating Neurological Disease in Patients With Gliomas
Official Title
Development of Activity MRI (aMRI): Direct Comparison to PET in Human Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This clinical trial develops a new metabolic imaging approach (activity magnetic resonance imaging [aMRI]) for use in diagnosing and evaluating neurological disease in patients with gliomas. 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
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 intravenously (IV) then 30 minutes later, receive gadoterate meglumine IV and undergo PET/contrast-enhanced MRI over 20 to 40 minutes on study. After completion of study intervention, patients are followed up at 24 hours and then up to 2 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (¹⁸FDG PET, contrast-enhanced MRI)
Arm Type
Experimental
Arm Description
Patients receive ¹⁸FDG IV then 30 minutes later, receive gadoterate meglumine IV and undergo PET/contrast-enhanced MRI over 20 to 40 minutes on study.
Intervention Type
Other
Intervention Name(s)
Fludeoxyglucose F-18
Other Intervention Name(s)
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
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Gadoterate Meglumine
Other Intervention Name(s)
92943-93-6, DOTAREM, Gd-DOTA
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Contrast-enhanced Magnetic Resonance Imaging
Other Intervention Name(s)
CONTRAST ENHANCED MRI, Contrast-enhanced MRI, MRI With Contrast
Intervention Description
Undergo PET/contrast-enhanced MRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, PET, PET Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Intervention Description
Undergo PET/contrast-enhanced MRI
Primary Outcome Measure Information:
Title
Mean values of kᵢₒ*V of the entire tumor region
Description
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 fludeoxyglucose 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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Mean value of kᵢₒ*V in the tumor periphery and core regions
Description
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.
Time Frame
Up to 1 year
Title
kᵢₒ*V in different normal appearing brain sub-regions, unaffected by tumor
Description
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. In future studies with a modified protocol, healthy controls maybe be utilized to further extend these studies.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (greater than 18 years of age) with glioma who require MRI and ¹⁸FDG-PET imaging. Exclusion Criteria: Pregnant or breastfeeding. Adults lacking capacity to consent not will be included in this study. All other vulnerable populations - children, pregnant women, and prisoners - will not be included. Contraindication to PET, MRI, ¹⁸FDG or intravenous gadolinium-based contrast agents. Claustrophobia. Weight greater than modality maximum capacity. Presence of metallic foreign body or implanted medical devices in body not documented as MRI safe according to the OHSU Department of Radiology Guidelines (including but not limited to cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants). Sickle cell disease. Reduced renal function, as determined by GFR < 45 mL/min/1.73 m2 based on a serum creatinine level obtained per OHSU Department of Radiology and OHSU Advanced Imaging Research Center (AIRC) clinical criteria. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ¹⁸FDG. Unsure of pregnancy status as assessed by Department of Radiology and AIRC guidelines. Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject. Poor peripheral intravenous access evaluated by patient history. Presence of other serious systemic illnesses, including: uncontrolled infection, other uncontrolled malignancy, uncontrolled diabetes type II, or psychiatric/social situations which might impact the endpoint of the study or limit compliance with study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Pike, Ph.D.
Phone
503-494-2951
Email
pikema@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Pike, Ph.D.
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Pike, Ph.D.
Phone
503-494-2951
Email
pikema@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Martin Pike, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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