NCT02885272

FDG PET Imaging in Diagnosing Patients With Glioblastoma

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Glioblastoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT scans
RADIATION	Fludeoxyglucose F-18	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo standard of care MRI
PROCEDURE	Positron Emission Tomography	Undergo PET/CT scans

Timeline

• Start date: 2016-10-28
• Primary completion: 2022-07-12
• Completion: 2022-07-12
• First posted: 2016-08-31
• Last updated: 2022-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study