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Completed

NCT Number: NCT02885272

FDG PET Imaging in Diagnosing Patients With Glioblastoma

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.

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Key information

Conditions

Brain Glioblastoma

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Procedure

Undergo PET/CT scans

Other names: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Fludeoxyglucose F-18

Radiation

Given IV

Other names: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Magnetic Resonance Imaging

Procedure

Undergo standard of care MRI

Other names: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Positron Emission Tomography

Procedure

Undergo PET/CT scans

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Primary outcomes

  1. Differences in length-beam ratio

    Time frame: Up to 2 years

    Will be tested via paired t-test after appropriate transformation.

  2. Quantitative parametric maps based on biophysical principles or pharmacokinetic modeling

    Time frame: Up to 2 years

    Will be derived from magnetic resonance advanced brain tumor imaging.

  3. Magnetic resonance images of relative blood volume, blood flow, apparent diffusion coefficient and forward volumetric transfer constant

    Time frame: Up to 2 years

    Will be used to derive quantitative parametric maps based on biophysical principles or pharmacokinetic modeling.

  4. Fluorodeoxyglucose F-18 uptake patterns

    Time frame: Up to 2 years

    Will be correlated with magnetic resonance images.

  5. Genotypic factors

    Time frame: Up to 2 years

    Will be assessed via two-sample t-tests, for all genes of interest with at least 20% of mutation prevalence.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2016
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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