Clinical trial NCT01089868: Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients
Official title: Quantification of Therapy Effects After Microsurgery, Percutaneous Irradiation and Chemotherapy by FET-PET Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma Multiforme
Keywords: Glioblastoma multiforme
Microsurgery
Stereotactic biopsy
Radiochemotherapy
Temodar
FET PET
Molecular imaging
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
First posted: 2010-03-19
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been referred to a neurosurgical department for diagnosis and therapy of a brain tumor

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.


Eligibility 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.

Primary outcomes:
measure: Overall Survival
timeFrame: 46 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 46 months
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Department of Stereotactic Neurosurgery
state: Baden Wuertemberg
city: Munich
country: Germany
facility: University Hospital Munich, Department of Neurosurgery
state: Bavaria
city: Bonn
country: Germany
facility: University Hospital Bonn, Department of Neurosurgery
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Neurosurgery, LMU, Munich
name: Joerg C. Tonn, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingrisch M, Schneider MJ, Norenberg D, Negrao de Figueiredo G, Maier-Hein K, Suchorska B, Schuller U, Albert N, Bruckmann H, Reiser M, Tonn JC, Ertl-Wagner B. Radiomic Analysis Reveals Prognostic Information in T1-Weighted Baseline Magnetic Resonance Imaging in Patients With Glioblastoma. Invest Radiol. 2017 Jun;52(6):360-366. doi: 10.1097/RLI.0000000000000349.