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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01089868

Enrollment

Registered

2010-03-19

Start date

2007-01-31

Completion date

2012-07-31

Last updated

2012-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma multiforme, Microsurgery, Stereotactic biopsy, Radiochemotherapy, Temodar, FET PET, Molecular imaging

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Overall Survival	46 months

Secondary

Measure	Time frame
Progression Free Survival	46 months

Countries

Germany

Outcome results