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Trial Title:
Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
NCT ID:
NCT01798771
Condition:
Primary Malignant Neoplasm of Nervous System
Glioma
Glioblastoma
Metastasis
Conditions: Official terms:
Glioblastoma
Brain Neoplasms
Neoplasms
Nervous System Neoplasms
Aminolevulinic Acid
Conditions: Keywords:
primary brain tumor
malignant glioma
intraoperative MRI
5-ALA
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Interventional arm
Description:
5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for
resection control in patients with contrast enhancing tumors.
Arm group label:
Interventional arm
Other name:
5-ALA
Other name:
5-Aminolevulinic acid hydrochloride
Intervention type:
Procedure
Intervention name:
Control arm
Description:
5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.
Arm group label:
Control arm
Other name:
5-ALA
Other name:
5-Aminolevulinic acid hydrochloride
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Klinik für Neurochirurgie Johann Wolfgang Goethe University
Address:
City:
Frankfurt am Main
Zip:
60528
Country:
Germany
Contact:
Last name:
Christian Senft, MD PhD
Phone:
069-6301
Phone ext:
5939
Email:
c.senft@med.uni-frankfurt.de
Start date:
March 2013
Completion date:
February 2016
Lead sponsor:
Agency:
Johann Wolfgang Goethe University Hospital
Agency class:
Other
Source:
Johann Wolfgang Goethe University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01798771
