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Trial Title:
Developing a New Metabolic Imaging Approach (aMRI) for Evaluating Neurological Disease in Patients With Gliomas
NCT ID:
NCT05937776
Condition:
Glioma
Conditions: Official terms:
Glioma
Deoxyglucose
Fluorodeoxyglucose F18
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Fludeoxyglucose F-18
Description:
Given IV
Arm group label:
Diagnostic (¹⁸FDG PET, MRI)
Other name:
¹⁸FDG
Other name:
2-Deoxy-2-(18F)Fluoro-D-Glucose
Other name:
2-F18-Fluoro-2-deoxy-D-glucose
Other name:
Fludeoxyglucose (18F)
Other name:
105851-17-0
Other name:
2-F18-Fluoro-2-deoxyglucose
Other name:
FDG
Other name:
fludeoxyglucose F 18
Other name:
Fluorine-18
Other name:
Fludeoxyglucose F18
Other name:
2-Fluoro-2-deoxy-D-Glucose
Intervention type:
Other
Intervention name:
Gadoterate Meglumine
Description:
Given IV
Arm group label:
Diagnostic (¹⁸FDG PET, MRI)
Other name:
92943-93-6
Other name:
DOTAREM
Other name:
Gd-DOTA
Intervention type:
Procedure
Intervention name:
Contrast-enhanced Magnetic Resonance Imaging
Description:
Undergo PET/contrast-enhanced MRI
Arm group label:
Diagnostic (¹⁸FDG PET, MRI)
Other name:
CONTRAST ENHANCED MRI
Other name:
Contrast-enhanced MRI
Other name:
MRI With Contrast
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/contrast-enhanced MRI
Arm group label:
Diagnostic (¹⁸FDG PET, MRI)
Other name:
Medical Imaging
Other name:
PET
Other name:
PET Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
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.
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.
Criteria for eligibility:
Study pop:
Adult patients with glioma
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Adult patients (greater than 18 years of age) with glioma who require MRI and
¹⁸FDG-PET imaging.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Martin Pike, Ph.D.
Phone:
503-494-2951
Email:
pikema@ohsu.edu
Investigator:
Last name:
Martin Pike, Ph.D.
Email:
Principal Investigator
Start date:
December 11, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Oregon Health and Science University
Agency class:
Other
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05937776
