Trial Information
Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas
Inclusion Criteria:
- supratentorial brain tumor, on contrast enhanced dMRI suspected to be GBM
- indication for gross total resection (GTR) of the tumor
- age ≥18 years
- WHO Performance Scale ≤ 2
- ASA class ≤ 3
- adequate knowledge of the Dutch or French language
- informed consent
Exclusion Criteria:
- recurrent brain tumor
- multiple brain tumor localizations
- earlier skull radiotherapy
- earlier chemotherapy for GBM
- Chronic Kidney Disease or other renal function disorder
- known MR-contrast allergy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Difference in Residual tumor volume
Outcome Time Frame:
<72h after surgery
Safety Issue:
No
Principal Investigator
Henk van Santbrink, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Maastricht University Medical Center
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
MEC 08-2-055
NCT ID:
NCT00943007
Start Date:
February 2010
Completion Date:
December 2013
Related Keywords:
- Glioblastoma Multiforme
- Brain Neoplasms
- Glioblastoma