FDG PET Imaging in Diagnosing Patients With Glioblastoma

NCT ID: NCT02885272

Last Updated: 2022-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-28

Study Completion Date

2022-07-12

Brief Summary

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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.

Detailed Description

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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

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Brain Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (PET/CT)

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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT scans

Fludeoxyglucose F-18

Intervention Type RADIATION

Given IV

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo standard of care MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT scans

Interventions

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Computed Tomography

Undergo PET/CT scans

Intervention Type PROCEDURE

Fludeoxyglucose F-18

Given IV

Intervention Type RADIATION

Magnetic Resonance Imaging

Undergo standard of care MRI

Intervention Type PROCEDURE

Positron Emission Tomography

Undergo PET/CT scans

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography computerized tomography CT CT SCAN tomography 18FDG FDG fludeoxyglucose F 18 Fludeoxyglucose F18 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose Fluorodeoxyglucose F18 Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason M Johnson

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2016-01971

Identifier Type: REGISTRY

Identifier Source: secondary_id

2016-0261

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-0261

Identifier Type: -

Identifier Source: org_study_id

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