FDG PET Imaging in Diagnosing Patients With Glioblastoma

Study Overview
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Brief Summary
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This early phase I trial studies the how well fluorodeoxyglucose F-18 (FDG) positron emission tomography (PET) imaging works in diagnosing patients with confirmed or suspected glioblastoma. Diagnostic procedures, such as FDG PET, may help find and diagnose glioblastoma.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the optimal FDG positron emission tomography (PET) imaging time post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background [L/B] ratio) in patients with glioblastoma. SECONDARY OBJECTIVES: I. To identify genotypic factors in FDG tumor metabolism derived from metrics such as maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), total lesion glycolysis (TLG), mean tumor volume (MTV) and L/B ratio. EXPLORATORY OBJECTIVES: I. To identify patterns of metabolism derived from metrics such as SUVmax, SUVmean, TLG, MTV, L/B ratio and magnetic resonance imaging metrics such as regional perfusion abnormalities, apparent diffusion coefficient values, fractional diffusivity measures and magnetic resonance spectroscopic finding. OUTLINE: Patients receive fluorodeoxyglucose F-18 intravenously (IV) over 1 minute and then undergo PET/computed tomography (CT) scans over 30 minutes at 1 hour, 4-5 hours, and 7-8 hours after injection. Patients also undergo a standard of care magnetic resonance imaging (MRI) scan over 45 minutes if not already completed as part of standard of care.

Official Title
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Dual Time Point FDG PET Imaging Optimization for the Evaluation of Glioblastoma

Conditions
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Brain Glioblastoma

Intervention / Treatment
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* Procedure: Computed Tomography
* Radiation: Fludeoxyglucose F-18
* Procedure: Magnetic Resonance Imaging
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (> 19 years of age) patients with biopsy proven (as opposed to being status post definitive surgical therapy) or highly suspected glioblastoma of the brain Cases without prior biopsy will be chosen based upon consensus of a MD Anderson faculty neuroradiologist and neurosurgeon for high probability of representing a glioblastoma T1 post contrast lesion size greater than or equal to 10 mm Exclusion Criteria: Children Definitive/gross total lesion resection Prior brain cancer Prior whole brain radiation Known history of cerebrovascular disease, dementia or prior non-mild traumatic brain injury Known allergy to FDG or gadolinium based contrast agents Pregnant women are excluded

Ages Eligible for Study
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Minimum Age: 19 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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (PET/CT)<br>Patients receive fluorodeoxyglucose F-18 IV over 1 minute and then undergo PET/CT scans over 30 minutes at 1 hour, 4-5 hours, and 7-8 hours after injection. Patients also undergo a standard of care MRI scan over 45 minutes if not already completed as part of standard of care. | Procedure: Computed Tomography<br>* Undergo PET/CT scans<br>* Other names: tomography;Radiation: Fludeoxyglucose F-18<br>* Given IV<br>* Other names: Fluorodeoxyglucose F18;Procedure: Magnetic Resonance Imaging<br>* Undergo standard of care MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Positron Emission Tomography<br>* Undergo PET/CT scans<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in length-beam ratio | Will be tested via paired t-test after appropriate transformation. | Up to 2 years | 
| Quantitative parametric maps based on biophysical principles or pharmacokinetic modeling | Will be derived from magnetic resonance advanced brain tumor imaging. | Up to 2 years | 
| Magnetic resonance images of relative blood volume, blood flow, apparent diffusion coefficient and forward volumetric transfer constant | Will be used to derive quantitative parametric maps based on biophysical principles or pharmacokinetic modeling. | Up to 2 years | 
| Fluorodeoxyglucose F-18 uptake patterns | Will be correlated with magnetic resonance images. | Up to 2 years | 
| Genotypic factors | Will be assessed via two-sample t-tests, for all genes of interest with at least 20% of mutation prevalence. | Up to 2 years |