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

Withdrawn

• Conditions: Glioblastoma; Glioma
• Interventions: Procedure: Computed Tomography; Radiation: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography

• Registration Number: NCT02919332
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-06-08
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Primary Completion: 2018-12-12
• Study Completion: 2018-12-12
• Status Verified: 2019-02
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic (18F-FDG PET/CT)	Computed Tomography	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.
Diagnostic (18F-FDG PET/CT)	Positron Emission Tomography	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.
Diagnostic (18F-FDG PET/CT)	Fludeoxyglucose F-18	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.

Primary Outcome Measures

Name	Time	Method
Tumor-to-background ratio on delayed scans (240 min after injection)	Baseline up to 240 minutes after injection	Ratio between Standardized uptake values (tumor region) and Standardized uptake values (physiological uptake of brain tissue)
Tumor-to-background ratio on standard scans (60 min after injection)	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

Name	Time	Method
Standard uptake value comparison	60 minutes post injection	Comparison of Standardized uptake values (tumor region) to visual and quantitative parameters on standard scans (60 min after injection)

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States