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

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Glioblastoma Multiforme

Study type: Observational

Funder types: Other

Identifiers

NCT01089868

GGN-ZP9

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

79 participants in 2 patient groups

Group A

Description:

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

Description:

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.