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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma
• Intervention / Treatment: Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Radiation: Fludeoxyglucose F-18

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soosan Roodbari; Phone Number: 310 794-1596; Email: sroodbari@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA / Jonsson Comprehensive Cancer Center
      • Contact: Soosan Roodbari; Phone Number: 310-794-1596; Email: sroodbari@mednet.ucla.edu
      • Principal Investigator: Johannes Czernin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (FDG PET/CT); 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.

Procedure: Computed Tomography; Undergo FDG PET/CT; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; tomography; CT SCAN; Procedure: Positron Emission Tomography; Undergo 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; Radiation: Fludeoxyglucose F-18; Undergo FDG PET/CT; Other Names: 18FDG; FDG; fludeoxyglucose F 18; Fludeoxyglucose F18; Fluorine-18 2-Fluoro-2-deoxy-D-Glucose; Fluorodeoxyglucose F18

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Johannes Czernin, MD, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2015
• Primary Completion (Estimated): August 25, 2024
• Study Completion (Estimated): August 25, 2025

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimated): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: FDG; PET/CT very early response (48 hrs)
• 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: 15-000409 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center); NCI-2016-00583 (Registry Identifier: CTRP (Clinical Trial Reporting Program))