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Completed

NCT Number: NCT01089868

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

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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Key information

Conditions

Glioblastoma Multiforme Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Stereotactic Neurosurgery, Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: 46 months

Secondary outcomes

  1. Progression Free Survival

    Time frame: 46 months

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

Registry information

Official study title

Quantification of Therapy Effects After Microsurgery, Percutaneous Irradiation and Chemotherapy by FET-PET Analysis

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Mar 19, 2010
Registry last updated
Aug 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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