Brain Glioblastoma
Conditions
Brief summary
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
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.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT scans
RADIATIONFludeoxyglucose F-18
Given IV
PROCEDUREMagnetic Resonance Imaging
Undergo standard of care MRI
PROCEDUREPositron Emission Tomography
Undergo PET/CT scans
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in length-beam ratio | Up to 2 years | Will be tested via paired t-test after appropriate transformation. |
| Quantitative parametric maps based on biophysical principles or pharmacokinetic modeling | Up to 2 years | Will be derived from magnetic resonance advanced brain tumor imaging. |
| Magnetic resonance images of relative blood volume, blood flow, apparent diffusion coefficient and forward volumetric transfer constant | Up to 2 years | Will be used to derive quantitative parametric maps based on biophysical principles or pharmacokinetic modeling. |
| Fluorodeoxyglucose F-18 uptake patterns | Up to 2 years | Will be correlated with magnetic resonance images. |
| Genotypic factors | Up to 2 years | Will be assessed via two-sample t-tests, for all genes of interest with at least 20% of mutation prevalence. |
Countries
United States
Outcome results
None listed