Delayed 18F-FDG PET/CT in Improving Visualization of Brain Tumors in Patients With Glioblastoma

Study Overview
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Brief Summary
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This clinical trial studies how well delayed fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) works in improving visualization of brain tumors in patients with glioblastoma. Radiotracers such as 18F-FDG are highly taken up by tumors in the brain and are visualized using PET/CT. Increasing the interval of time between 18F-FDG administration and PET/CT scan may improve the visualization of brain tumors in patients with glioblastoma.

Detailed Description
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PRIMARY OBJECTIVES: I. To improve the visualization/delineation of glioblastoma lesions using delayed 18F-FDG PET/CT imaging. OUTLINE: Patients receive fludeoxyglucose F-18 intravenously (IV). Patients then undergo a standard of care PET/CT scan at 60 minutes and a second PET/CT scan at 240 minutes after injection. Note: Standard Uptake Value (SUV) is defined for state-of-the art PET/CT scanners as Standardized uptake values = count activity per ml within region of interest (MBq/ml)/[injected dose (MBq)/body weight (kgx1000)]

Official Title
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Improved Visualization of Glioblastoma Using Delayed 18F-FDG PET/CT.

Conditions
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Glioblastoma, Glioma

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically proven high grade glioma scheduled for 18F-FDG PET/CT Exclusion Criteria: Severe psychiatric illness Inability to give written consent Breast feeding/pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 (18F-FDG PET/CT)<br>Patients receive fludeoxyglucose F-18 IV. Patients then undergo a standard of care PET/CT scan at 60 minutes and a second PET/CT scan at 240 minutes after injection. | Procedure: Computed Tomography<br>* Undergo 18F-FDG PET/CT<br>* Other names: tomography;Radiation: Fludeoxyglucose F-18<br>* Given IV<br>* Other names: Fluorodeoxyglucose F18;Procedure: Positron Emission Tomography<br>* Undergo 18F-FDG PET/CT<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 |
| --- | --- | --- |
| Tumor-to-background ratio on delayed scans (240 min after injection) | Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue) | Baseline up to 240 minutes after injection | 
| Tumor-to-background ratio on standard scans (60 min after injection) | Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue) | Baseline up to 60 minutes after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard uptake value comparison | Comparison of Standardized uptake values (tumor region) to visual and quantitative parameters on delayed scans (240 min after injection) | 240 minutes post injection | 
| Standard uptake value comparison | Comparison of Standardized uptake values (tumor region) to visual and quantitative parameters on standard scans (60 min after injection) | 60 minutes post injection |