NCT02919332

Brief Summary

This clinical trial studies how well delayed fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) works in improving visualization of brain tumors in patients with glioblastoma. Radiotracers such as 18F-FDG are highly taken up by tumors in the brain and are visualized using PET/CT. Increasing the interval of time between 18F-FDG administration and PET/CT scan may improve the visualization of brain tumors in patients with glioblastoma.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

June 8, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed
Last Updated

July 24, 2020

Status Verified

February 1, 2019

Enrollment Period

2.5 years

First QC Date

August 30, 2016

Last Update Submit

July 22, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Tumor-to-background ratio on delayed scans (240 min after injection)

    Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue)

    Baseline up to 240 minutes after injection

  • Tumor-to-background ratio on standard scans (60 min after injection)

    Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue)

    Baseline up to 60 minutes after injection

Secondary Outcomes (2)

  • Standard uptake value comparison

    240 minutes post injection

  • Standard uptake value comparison

    60 minutes post injection

Study Arms (1)

Diagnostic (18F-FDG PET/CT)

Patients receive fludeoxyglucose F-18 IV. Patients then undergo a standard of care PET/CT scan at 60 minutes and a second PET/CT scan at 240 minutes after injection.

Procedure: Computed TomographyRadiation: Fludeoxyglucose F-18Procedure: Positron Emission Tomography

Interventions

Undergo 18F-FDG PET/CT

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

Given IV

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

Undergo 18F-FDG PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (18F-FDG PET/CT)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients older than 18 years of age who have been diagnosed with a brain tumor and are undergoing a PET/CT scan..

You may qualify if:

  • Patients with histologically proven high grade glioma scheduled for 18F-FDG PET/CT

You may not qualify if:

  • Severe psychiatric illness
  • Inability to give written consent
  • Breast feeding/pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

GlioblastomaGlioma

Interventions

Fluorodeoxyglucose F18Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

AstrocytomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Johannes Czernin

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 29, 2016

Study Start

June 8, 2016

Primary Completion

December 12, 2018

Study Completion

December 12, 2018

Last Updated

July 24, 2020

Record last verified: 2019-02

Locations