NCT02885272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Oct 2016

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 28, 2016

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

5.7 years

First QC Date

August 26, 2016

Last Update Submit

July 18, 2022

Conditions

Brain Glioblastoma

Outcome Measures

Primary Outcomes (5)

  • Differences in length-beam ratio

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

    Up to 2 years

  • Quantitative parametric maps based on biophysical principles or pharmacokinetic modeling

    Will be derived from magnetic resonance advanced brain tumor imaging.

    Up to 2 years

  • 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.

    Up to 2 years

  • Fluorodeoxyglucose F-18 uptake patterns

    Will be correlated with magnetic resonance images.

    Up to 2 years

  • Genotypic factors

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

    Up to 2 years

Study Arms (1)

Diagnostic (PET/CT)

EXPERIMENTAL

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 TomographyRadiation: Fludeoxyglucose F-18Procedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT scans

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Diagnostic (PET/CT)
Fludeoxyglucose F-18RADIATION

Given IV

Also known as: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Diagnostic (PET/CT)
Magnetic Resonance ImagingPROCEDURE

Undergo standard of care MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Diagnostic (PET/CT)
Positron Emission TomographyPROCEDURE

Undergo PET/CT scans

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (PET/CT)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Fluorodeoxyglucose F18Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jason M Johnson

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

October 28, 2016

Primary Completion

July 12, 2022

Study Completion

July 12, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations

US(1)