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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Glioma; Glioblastoma
• Intervention / Treatment: Radiation: Fludeoxyglucose F-18; Procedure: Computed Tomography; 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

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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..

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

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: Computed Tomography; Undergo 18F-FDG PET/CT; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; tomography; CT SCAN; Procedure: Positron Emission Tomography; Undergo 18F-FDG PET/CT; Other Names: Medical Imaging, Positron Emission Tomography; PET; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; PET SCAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2016
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): December 12, 2018

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimate): September 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Radiopharmaceuticals; Fluorodeoxyglucose F18; Deoxyglucose
• Other Study ID Numbers: 16-000600 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center); NCI-2016-01214 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); JCCCID655 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center)