Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Quantification of Therapy Effects After Microsurgery, Percutaneous Irradiation and Chemotherapy by FET-PET Analysis|
- Overall Survival [ Time Frame: 46 months ] [ Designated as safety issue: No ]
- Progression Free Survival [ Time Frame: 46 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
DNA and RNA samples for MGMT methylation and LOH 1p and 19q status analysis
|Study Start Date:||January 2007|
|Study Completion Date:||July 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Patients who suffer from a suspected GBM and will undergo a microsurgical procedure for diagnosis verification. MRI and Positron Emission Tomography (PET) scans are scheduled prior to microsurgery, post microsurgery and after having completed radiochemotherapy and an additional scan after TMZ chemotherapy.
Patients enrolled in Group B suffer from a suspected GBM which cannot be accessed microsurgically either due to a an eloquent location of the tumor, or patient's refusal to undergo surgery. In these patients, diagnosis will be obtained by means of stereotactic surgery. After an initial PET and MRI scan prior to biopsy, patients will be monitored by post radiochemotherapy as well as post 3-months chemotherapy MRI/PET scans.
|Department of Stereotactic Neurosurgery|
|Freiburg, Baden Wuertemberg, Germany, 79095|
|University Hospital Munich, Department of Neurosurgery|
|Munich, Bavaria, Germany, 81377|
|University Hospital Bonn, Department of Neurosurgery|
|Bonn, North Rhine-Westphalia, Germany, 53127|
|Principal Investigator:||Joerg C. Tonn, Prof. Dr.||Department of Neurosurgery, LMU, Munich|