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NCT02902757 Clinical Trial

FDG PET/CT in Monitoring Very Early Therapy Response in Patients With Glioblastoma

Glioblastoma Clinical Trial

Official title:
Very Early Response Monitoring in Patients With Glioblastoma Undergoing Therapy Using FDG PET/CT

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02902757
Other study ID # 15-000409
Secondary ID NCI-2016-0058315
Status Recruiting
Phase N/A
First received
Last updated
Start date August 25, 2015
Est. completion date August 25, 2025

Study information
Verified date November 2023
Source Jonsson Comprehensive Cancer Center
Contact Soosan Roodbari
Phone 310 794-1596
Email sroodbari@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) in monitoring very early therapy response in patients with glioblastoma. Diagnostic procedures, such as FDG PET/CT, may help measure a patient's response to earlier treatment. Chemotherapy can induce very rapid changes to the tumor's glucose consumption which can be measured with imaging. FDG PET/CT shortly after the start of therapy may help identify very early therapy response in patients with glioblastoma.

Description:

PRIMARY OBJECTIVES: I. To assess very early response to therapy in glioblastoma patients using 18F-FDG PET/CT. II. Evaluate very early changes in FDG uptake within 48 hours of start of therapy and correlate them with objective response parameters such as Response Assessment in Neuro-Oncology (RANO) and survival. OUTLINE: Patients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date August 25, 2025
Est. primary completion date August 25, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patients with histologically proven high grade glioma - Intention to start therapy Exclusion Criteria: - Severe psychiatric illness - Inability to give written consent - Breast feeding / pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

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

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

Sponsors (3)
Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in glucose uptake Standardized uptake values (SUV) will be calculated for different organs and for regions of tumor. Further, regional target to background count-activity ratios will be established. From baseline up to 48 hours
Primary Very early changes in tumor glucose uptake predictive for objective treatments response and survival assessed using RANO criteria SUV will be calculated for different organs and for regions of tumor. Further, regional target to background count-activity ratios will be established. One PET/CT 48 hours after start of therapy
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