FDG PET Imaging in Diagnosing Patients With Glioblastoma

Early Phase 1

Completed

• Conditions: Brain Glioblastoma
• Interventions: Procedure: Computed Tomography; Radiation: Fludeoxyglucose F-18; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

• Registration Number: NCT02885272
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-08-31
• Study Start: 2016-10-28
• Status Verified: 2022-07
• Primary Completion: 2022-07-12
• Study Completion: 2022-07-12
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (PET/CT)	Computed Tomography	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.
Diagnostic (PET/CT)	Magnetic Resonance Imaging	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.
Diagnostic (PET/CT)	Fludeoxyglucose F-18	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.
Diagnostic (PET/CT)	Positron Emission Tomography	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States