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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glioblastoma

Intervention / Treatment
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* Procedure: Computed Tomography
* Radiation: Fludeoxyglucose F-18
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (FDG PET/CT)<br>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<br>* Undergo FDG PET/CT<br>* Other names: tomography;Radiation: Fludeoxyglucose F-18<br>* Undergo FDG PET/CT<br>* Other names: Fluorodeoxyglucose F18;Procedure: Positron Emission Tomography<br>* Undergo FDG PET/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FDG, PET/CT very early response (48 hrs)