Status:
COMPLETED
Impact of [11C]-Methionine PET/MRI for Individual Tailoring Postoperative Radiochemotherapy for Glioblastoma Multiforme
Lead Sponsor:
Technische Universität Dresden
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Brief Summary
Local recurrence is a major problem of clinical treatment of glioblastoma multiforme (GBM). Today a very sensitive imaging method to detect glioblastoma is \[11C\]MET Positron emission tomography (PET...
Detailed Description
The current study aims to investigate the association of high \[11C\]MET tracer uptake before postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in patients with...
Eligibility Criteria
Inclusion
- 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
- previous radiotherapy of the brain or chemotherapy with TMZ other than during the radiochemotherapy
- 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
- refusal of the patients to take part in the study
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01873469
Start Date
July 1 2013
End Date
October 1 2018
Last Update
February 18 2019
Active Locations (1)
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1
Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Oncology; and DKTK partner site Dresden
Dresden, Saxony, Germany, 01307