Impact of [11C]-methionine PET/MRI as a tool for individual tailoring postoperative radiochemotherapy for patients with glioblastoma multiforme REG-Nr. NCT01873469 |
Study Design | One-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
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Therapy | Investigate 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 |