FDG PET Imaging in Diagnosing Patients With Glioblastoma

M.D. Anderson Cancer Center

Status and phase: Completed; Early Phase 1

Conditions: Brain Glioblastoma

Treatments: Procedure: Positron Emission Tomography; Radiation: Fludeoxyglucose F-18; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02885272

P30CA016672 (U.S. NIH Grant/Contract)

2016-0261 (Other Identifier)

NCI-2016-01971 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Diagnostic (PET/CT)

Experimental group

Description:

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.

Treatment:

Procedure: Magnetic Resonance Imaging

Procedure: Computed Tomography

Radiation: Fludeoxyglucose F-18

Procedure: Positron Emission Tomography