Developing a New Metabolic Imaging Approach (aMRI) for Evaluating Neurological Disease in Patients With Gliomas
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
PRIMARY OBJECTIVE:
- 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:
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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).
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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:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Diagnostic (¹⁸FDG PET, contrast-enhanced MRI) 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. |
Other: Fludeoxyglucose F-18
Given IV
Other Names:
Other: Gadoterate Meglumine
Given IV
Other Names:
Procedure: Contrast-enhanced Magnetic Resonance Imaging
Undergo PET/contrast-enhanced MRI
Other Names:
Procedure: Positron Emission Tomography
Undergo PET/contrast-enhanced MRI
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean values of kᵢₒ*V of the entire tumor region [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 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 [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.
- kᵢₒ*V in different normal appearing brain sub-regions, unaffected by tumor [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. In future studies with a modified protocol, healthy controls maybe be utilized to further extend these studies.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult patients (greater than 18 years of age) with glioma who require MRI and ¹⁸FDG-PET imaging.
Exclusion Criteria:
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Pregnant or breastfeeding.
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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.
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Contraindication to PET, MRI, ¹⁸FDG or intravenous gadolinium-based contrast agents.
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Claustrophobia.
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Weight greater than modality maximum capacity.
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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).
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Sickle cell disease.
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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.
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History of allergic reactions attributed to compounds of similar chemical or biologic composition to ¹⁸FDG.
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Unsure of pregnancy status as assessed by Department of Radiology and AIRC guidelines.
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Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject.
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Poor peripheral intravenous access evaluated by patient history.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OHSU Knight Cancer Institute | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- OHSU Knight Cancer Institute
- Oregon Health and Science University
Investigators
- Principal Investigator: Martin Pike, Ph.D., OHSU Knight Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00024504