FDG PET Imaging in Diagnosing Patients With Glioblastoma

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT02885272
Collaborator
National Cancer Institute (NCI) (NIH)
21
1
1
68.4
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Computed Tomography
  • Radiation: Fludeoxyglucose F-18
  • Procedure: Magnetic Resonance Imaging
  • Procedure: Positron Emission Tomography
Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Dual Time Point FDG PET Imaging Optimization for the Evaluation of Glioblastoma
Actual Study Start Date :
Oct 28, 2016
Actual Primary Completion Date :
Jul 12, 2022
Actual Study Completion Date :
Jul 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: Computed Tomography
Undergo PET/CT scans
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography
  • Radiation: Fludeoxyglucose F-18
    Given IV
    Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18
  • Procedure: Magnetic Resonance Imaging
    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
  • Procedure: Positron Emission Tomography
    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
  • Outcome Measures

    Primary Outcome Measures

    1. Differences in length-beam ratio [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 [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 [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 [Up to 2 years]

      Will be correlated with magnetic resonance images.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jason M Johnson, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02885272
    Other Study ID Numbers:
    • 2016-0261
    • NCI-2016-01971
    • 2016-0261
    • P30CA016672
    First Posted:
    Aug 31, 2016
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2022