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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01089868
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : August 7, 2012
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Bogdana Suchorska, Ludwig-Maximilians - University of Munich

March 17, 2010
March 19, 2010
August 7, 2012
January 2007
June 2011   (Final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 46 months ]
Same as current
Complete list of historical versions of study NCT01089868 on Archive Site
Progression Free Survival [ Time Frame: 46 months ]
Same as current
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Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients
Quantification of Therapy Effects After Microsurgery, Percutaneous Irradiation and Chemotherapy by FET-PET Analysis
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
DNA and RNA samples for MGMT methylation and LOH 1p and 19q status analysis
Non-Probability Sample
Patients who have been referred to a neurosurgical department for diagnosis and therapy of a brain tumor
Glioblastoma Multiforme
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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.
  • 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.
Ingrisch M, Schneider MJ, Nörenberg D, Negrao de Figueiredo G, Maier-Hein K, Suchorska B, Schüller U, Albert N, Brückmann 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2012
June 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Bogdana Suchorska, Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
Deutsche Krebshilfe e.V., Bonn (Germany)
Principal Investigator: Joerg C. Tonn, Prof. Dr. Department of Neurosurgery, LMU, Munich
Ludwig-Maximilians - University of Munich
August 2012