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Delayed 18F-FDG PET/CT in Improving Visualization of Brain Tumors in Patients With Glioblastoma

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ClinicalTrials.gov Identifier: NCT02919332
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment
Glioblastoma Glioma Procedure: Computed Tomography Radiation: Fludeoxyglucose F-18 Procedure: Positron Emission Tomography

Detailed Description:

PRIMARY OBJECTIVES:

I. To improve the visualization/delineation of glioblastoma lesions using delayed 18F-FDG PET/CT imaging.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (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.

Note:

Standard Uptake Value (SUV) is defined for state-of-the art PET/CT scanners as Standardized uptake values = count activity per ml within region of interest (MBq/ml)/[injected dose (MBq)/body weight (kgx1000)]


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Visualization of Glioblastoma Using Delayed 18F-FDG PET/CT.
Actual Study Start Date : June 8, 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 Tomography
Undergo 18F-FDG PET/CT
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: Positron Emission Tomography
Undergo 18F-FDG PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Tumor-to-background ratio on delayed scans (240 min after injection) [ Time Frame: Baseline up to 240 minutes after injection ]
    Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue)

  2. Tumor-to-background ratio on standard scans (60 min after injection) [ Time Frame: Baseline up to 60 minutes after injection ]
    Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue)


Secondary Outcome Measures :
  1. Standard uptake value comparison [ Time Frame: 240 minutes post injection ]
    Comparison of Standardized uptake values (tumor region) to visual and quantitative parameters on delayed scans (240 min after injection)

  2. Standard uptake value comparison [ Time Frame: 60 minutes post injection ]
    Comparison of Standardized uptake values (tumor region) to visual and quantitative parameters on standard scans (60 min after injection)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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..
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919332


Locations
United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Johannes Czernin    310-794-1005      
Principal Investigator: Johannes Czernin         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Johannes Czernin UCLA / Jonsson Comprehensive Cancer Center

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02919332     History of Changes
Other Study ID Numbers: 16-000600
NCI-2016-01214 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
16-000600 JCCCID655
16-000600 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action