Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients
NCT ID: NCT01089868
Last Updated: 2012-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
79 participants
OBSERVATIONAL
2007-01-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A
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.
No interventions assigned to this group
Group B
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Bogdana Suchorska
PI
Principal Investigators
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Joerg C. Tonn, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, LMU, Munich
Locations
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Department of Stereotactic Neurosurgery
Freiburg im Breisgau, Baden-Wurttemberg, Germany
University Hospital Munich, Department of Neurosurgery
Munich, Bavaria, Germany
University Hospital Bonn, Department of Neurosurgery
Bonn, North Rhine-Westphalia, Germany
Countries
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References
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Ingrisch M, Schneider MJ, Norenberg D, Negrao de Figueiredo G, Maier-Hein K, Suchorska B, Schuller U, Albert N, Bruckmann H, Reiser M, Tonn JC, Ertl-Wagner B. Radiomic Analysis Reveals Prognostic Information in T1-Weighted Baseline Magnetic Resonance Imaging in Patients With Glioblastoma. Invest Radiol. 2017 Jun;52(6):360-366. doi: 10.1097/RLI.0000000000000349.
Other Identifiers
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GGN-ZP9
Identifier Type: -
Identifier Source: org_study_id