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

This study has been completed.
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Bogdana Suchorska, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01089868
First received: March 17, 2010
Last updated: August 5, 2012
Last verified: August 2012
  Purpose

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
Glioblastoma Multiforme

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantification of Therapy Effects After Microsurgery, Percutaneous Irradiation and Chemotherapy by FET-PET Analysis

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 46 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 79
Study Start Date: January 2007
Study Completion Date: July 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089868

Locations
Germany
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)
Investigators
Principal Investigator: Joerg C. Tonn, Prof. Dr. Department of Neurosurgery, LMU, Munich
  More Information

No publications provided

Responsible Party: Bogdana Suchorska, PI, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01089868     History of Changes
Other Study ID Numbers: GGN-ZP9
Study First Received: March 17, 2010
Last Updated: August 5, 2012
Health Authority: Germany: Federal Office for Radiation Protection

Keywords provided by Ludwig-Maximilians - University of Munich:
Glioblastoma multiforme
Microsurgery
Stereotactic biopsy
Radiochemotherapy
Temodar
FET PET
Molecular imaging

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

ClinicalTrials.gov processed this record on July 28, 2014