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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089868
• Other study ID #: GGN-ZP9
• Status: Completed
• Phase: N/A
• First received: March 17, 2010
• Last updated: August 5, 2012
• Start date: January 2007
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Office for Radiation Protection
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Locations

Country	Name	City	State
Germany	University Hospital Bonn, Department of Neurosurgery	Bonn	North Rhine-Westphalia
Germany	Department of Stereotactic Neurosurgery	Freiburg	Baden Wuertemberg
Germany	University Hospital Munich, Department of Neurosurgery	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		46 months	No
Secondary	Progression Free Survival		46 months	No