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

Not Applicable

Recruiting

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

• Registration Number: NCT02902757
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief 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.

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 Timeline

• Study Start: 2015-08-25
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-08-25
• Study Completion: 2026-08-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in glucose uptake	From baseline up to 48 hours	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.
Very early changes in tumor glucose uptake predictive for objective treatments response and survival assessed using RANO criteria	One PET/CT 48 hours after start of therapy	SUV will be calculated for different organs and for regions of tumor. Further, regional target to background count-activity ratios will be established.

Trial Locations

Locations (1)

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