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NCT02919332 Clinical Trial

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

Glioblastoma Clinical Trial

Official title:
Improved Visualization of Glioblastoma Using Delayed 18F-FDG PET/CT.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02919332
Other study ID # 16-000600
Secondary ID NCI-2016-01214JC
Status Withdrawn
Phase
First received
Last updated
Start date June 8, 2016
Est. completion date December 12, 2018

Study information
Verified date February 2019
Source Jonsson Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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)]

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 12, 2018
Est. primary completion date December 12, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Computed Tomography
Undergo 18F-FDG PET/CT
Radiation:
• Fludeoxyglucose F-18
Given IV
Procedure:
• Positron Emission Tomography
Undergo 18F-FDG PET/CT

Locations
Country Name City State
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Standard uptake value comparison Comparison of Standardized uptake values (tumor region) to visual and quantitative parameters on delayed scans (240 min after injection) 240 minutes post injection
Secondary Standard uptake value comparison Comparison of Standardized uptake values (tumor region) to visual and quantitative parameters on standard scans (60 min after injection) 60 minutes post injection
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