Trial Information
Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
Inclusion Criteria:
- adult patient (> 18 years) able to give informed consent
- primary supratentorial intra-axial brain tumor exhibiting contrast enhancement
suspected to be malignant glioma
- tumor must be deemed completely resectable by neurosurgeon
- diagnostic MRI
Exclusion Criteria:
- patient unable or unwilling to give informed consent
- infratentorial tumor location
- tumor location in or near eloquent areas
- multifocal tumor
- existance of contraindications to undergo MRI examination
- previous surgical treatment for an intraaxial brain tumor
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Extent of Resection
Outcome Description:
The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.
Outcome Time Frame:
Early postoperative MRI within 72 hrs
Safety Issue:
No
Principal Investigator
Christian Senft, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dept. of Neurosurgery, Johann Wolfgang Goethe University Hospital
Authority:
Germany: Ethics Commission
Study ID:
JohannWGUH_IMAGER
NCT ID:
NCT01798771
Start Date:
March 2013
Completion Date:
February 2016
Related Keywords:
- Primary Malignant Neoplasm of Nervous System
- Glioma
- Glioblastoma
- Metastasis
- primary brain tumor
- malignant glioma
- intraoperative MRI
- 5-ALA
- Brain Neoplasms
- Neoplasms
- Glioblastoma
- Glioma
- Neoplasm Metastasis
- Nervous System Neoplasms