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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01971 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2016-0261 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (PET/CT) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET/CT scans |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason M Johnson | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
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| Fludeoxyglucose F-18 | Radiation | Given IV |
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| Magnetic Resonance Imaging | Procedure | Undergo standard of care MRI |
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| Positron Emission Tomography | Procedure | Undergo PET/CT scans |
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| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |