Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients

Completed

• Conditions: Glioblastoma Multiforme

• Registration Number: NCT01089868
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

The aim of this study is to establish FET-PET as an additional therapy assessment parameter in patients diagnosed with a glioblastoma multiforme receiving radiochemotherapy and adjuvant chemotherapy after previous resection or biopsy.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-19
• Primary Completion: 2011-06
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-05
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• neuroradiologically suspected Glioblastoma multiforme
• histological verification will be obtained either by microsurgery or by stereotactic biopsy. The neuropathological diagnosis will be verified by a reference neuropathologist
• patients will undergo radiochemotherapy subsequent to surgical procedure
• patients older than 18 years
• Karnofsky Performance Score >=70
• pregnant or nursing female patients will not be included in this study
• safe contraceptive methods during the radiochemotherapy and chemotherapy

Exclusion Criteria

• patients in whom informed consent cannot be obtained due to organic brain syndrome or insufficient language skills
• patients who cannot lie quiet for a time period of app. two hours during the FET-PEt scan
• medical history of a metastatic brain disease
• patients in whom an MRI scan cannot be performed due to claustrophobia metallic protheses or pacemakers etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	46 months

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	46 months

Trial Locations

Locations (3)

Department of Stereotactic Neurosurgery; 🇩🇪 Freiburg, Baden Wuertemberg, Germany

University Hospital Munich, Department of Neurosurgery; 🇩🇪 Munich, Bavaria, Germany

University Hospital Bonn, Department of Neurosurgery; 🇩🇪 Bonn, North Rhine-Westphalia, Germany