PETra

Impact of [11C]-methionine PET/MRI as a tool for individual tailoring postoperative radiochemotherapy for patients with glioblastoma multiforme

REG-Nr. NCT01873469

Indication: glioblastoma multiforme (GBM)

Inclusion criteria:

• Histologically confirmed newly diagnosed glioblastoma multiforme
• Macroscopic total tumour resection or biopsy
• Indication for combined radiochemotherapy with temozolomide
• Patients are allowed to take part in other clinical trials at the same time
• Beginning of radiochemotherapy no later than 7 weeks after surgery
• Karnofsky Performance Score ≥ 60, ECOG ≤2
• Women with childbearing potential, (and men) adequate contraception
• Ability of subject to understand character and individual consequences of the clinical trial
• Written informed consent

Exclusion criteria:

• Refusal of the patients to take part in the study
• Previous radiotherapy of the brain or chemotherapy with TMZ other than during the radiochemotherapy stated in the inclusion criteria
• Time interval of > 7 weeks after surgery and beginning of radiochemotherapy
• Patients who are not suitable for radiochemotherapy
• Known other malignant disease that impacts prognosis of the patient and/or is likely to require treatment interfering with study therapy
• Pregnant or lactating women
• Patients with non-MRI compatible metal implants, pacemaker or non-MRI compatible external automatic defibrillators, insulin pumps, neurostimulators, cochlear implants
• Claustrophobic patients
• Patients not able to understand the character and individual consequences of the trial

79 patients in total

Start patient inclusion: July 2013

End patient inclusion: expected July 2016