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


REG-Nr. NCT01873469

Study DesignOne-arm, single-center, non-randomized prognostic factor (biomarker) study
Study Population

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
TherapyInvestigate the association of high [11C]MET tracer uptake before postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in patients with glioblastoma multiforme.
Number of patients and timeline

79 patients in total

Start patient inclusion: July 2013

End patient inclusion: expected July 2016