Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients
This study has been completed.
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Bogdana Suchorska, Ludwig-Maximilians - University of Munich
First received: March 17, 2010
Last updated: August 5, 2012
Last verified: August 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Quantification of Therapy Effects After Microsurgery, Percutaneous Irradiation and Chemotherapy by FET-PET Analysis
Primary Outcome Measures:
- Overall Survival [ Time Frame: 46 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
- Progression Free Survival [ Time Frame: 46 months ] [ Designated as safety issue: No ]
DNA and RNA samples for MGMT methylation and LOH 1p and 19q status analysis
| Study Start Date:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients who have been referred to a neurosurgical department for diagnosis and therapy of a brain tumor
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01089868
|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 |
Ludwig-Maximilians - University of Munich
Deutsche Krebshilfe e.V., Bonn (Germany)
||Joerg C. Tonn, Prof. Dr.
||Department of Neurosurgery, LMU, Munich
No publications provided
||Bogdana Suchorska, PI, Ludwig-Maximilians - University of Munich
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 17, 2010
||August 5, 2012
||Germany: Federal Office for Radiation Protection
Keywords provided by Ludwig-Maximilians - University of Munich:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 01, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue