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

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.

Condition or disease
Glioblastoma Multiforme

Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantification of Therapy Effects After Microsurgery, Percutaneous Irradiation and Chemotherapy by FET-PET Analysis
Study Start Date : January 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 46 months ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 46 months ]

Biospecimen Retention:   Samples With DNA
DNA and RNA samples for MGMT methylation and LOH 1p and 19q status analysis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been referred to a neurosurgical department for diagnosis and therapy of a brain tumor

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Deutsche Krebshilfe e.V., Bonn (Germany)
Principal Investigator: Joerg C. Tonn, Prof. Dr. Department of Neurosurgery, LMU, Munich

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bogdana Suchorska, PI, Ludwig-Maximilians - University of Munich Identifier: NCT01089868     History of Changes
Other Study ID Numbers: GGN-ZP9
First Posted: March 19, 2010    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012

Keywords provided by Bogdana Suchorska, Ludwig-Maximilians - University of Munich:
Glioblastoma multiforme
Stereotactic biopsy
Molecular imaging

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue