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

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Completed

CT.gov ID

NCT01089868

Collaborator

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

Enrollment

Locations

Duration (Months)

26.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Glioblastoma Multiforme

Study Design

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 :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Overall Survival [46 months]

Secondary Outcome Measures

Progression Free Survival [46 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Stereotactic Neurosurgery	Freiburg	Baden Wuertemberg	Germany	79095
2	University Hospital Munich, Department of Neurosurgery	Munich	Bavaria	Germany	81377
3	University Hospital Bonn, Department of Neurosurgery	Bonn	North Rhine-Westphalia	Germany	53127