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Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
Conditions
Primary Malignant Neoplasm of Nervous System - Glioma - Glioblastoma - Metastasis
Conditions: official terms
Brain Neoplasms - Neoplasms - Nervous System Neoplasms
Conditions: Keywords
primary brain tumor, malignant glioma, intraoperative MRI, 5-ALA
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Interventional arm
Type: Procedure
Name: Control arm
Type: Procedure
Overall Status
Not yet recruiting
Summary
The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
Klinik für Neurochirurgie Johann Wolfgang Goethe University
Frankfurt am Main, Hessen, Germany
Status: Recruiting
Contact: Christian Senft, MD PhD - 069-6301 - c.senft@med.uni-frankfurt.de
Start Date
March 2013
Completion Date
February 2016
Sponsors
Johann Wolfgang Goethe University Hospitals
Source
Johann Wolfgang Goethe University Hospitals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page