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FDG PET Imaging in Diagnosing Patients With Glioblastoma

Primary Purpose

Brain Glioblastoma

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Fludeoxyglucose F-18
Magnetic Resonance Imaging
Positron Emission Tomography
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Glioblastoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (PET/CT)

Arm 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.

Outcomes

Primary Outcome Measures

Differences in length-beam ratio
Will be tested via paired t-test after appropriate transformation.
Quantitative parametric maps based on biophysical principles or pharmacokinetic modeling
Will be derived from magnetic resonance advanced brain tumor imaging.
Magnetic resonance images of relative blood volume, blood flow, apparent diffusion coefficient and forward volumetric transfer constant
Will be used to derive quantitative parametric maps based on biophysical principles or pharmacokinetic modeling.
Fluorodeoxyglucose F-18 uptake patterns
Will be correlated with magnetic resonance images.
Genotypic factors
Will be assessed via two-sample t-tests, for all genes of interest with at least 20% of mutation prevalence.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2016
Last Updated
July 18, 2022
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02885272
Brief Title
FDG PET Imaging in Diagnosing Patients With Glioblastoma
Official Title
Dual Time Point FDG PET Imaging Optimization for the Evaluation of Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 28, 2016 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Glioblastoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (PET/CT)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Intervention Description
Undergo PET/CT scans
Intervention Type
Radiation
Intervention Name(s)
Fludeoxyglucose F-18
Other Intervention Name(s)
18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo standard of care MRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET/CT scans
Primary Outcome Measure Information:
Title
Differences in length-beam ratio
Description
Will be tested via paired t-test after appropriate transformation.
Time Frame
Up to 2 years
Title
Quantitative parametric maps based on biophysical principles or pharmacokinetic modeling
Description
Will be derived from magnetic resonance advanced brain tumor imaging.
Time Frame
Up to 2 years
Title
Magnetic resonance images of relative blood volume, blood flow, apparent diffusion coefficient and forward volumetric transfer constant
Description
Will be used to derive quantitative parametric maps based on biophysical principles or pharmacokinetic modeling.
Time Frame
Up to 2 years
Title
Fluorodeoxyglucose F-18 uptake patterns
Description
Will be correlated with magnetic resonance images.
Time Frame
Up to 2 years
Title
Genotypic factors
Description
Will be assessed via two-sample t-tests, for all genes of interest with at least 20% of mutation prevalence.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Johnson
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

FDG PET Imaging in Diagnosing Patients With Glioblastoma

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