Trial Information
Comparison of Two Neuro-navigational Systems for Resection-control of Intra-axial Brain Tumors. The PoleStarN-20 Intra-operative Magnet Resonance Imager and the Mison SonoWand Intra-operative Ultrasound System
Inclusion Criteria:
- Patients must have neuro-radiological evidence of a brain lesion. Eligible are all
histological types of brain lesions.
- > 18 years of age.
- Male and female.
- Patient must be a surgical candidate, according to general anesthetic and
neurosurgical criteria.
- Patient should be able to undergo MRI.
- Informed consent as per protocol.
Exclusion Criteria:
- Patient unwilling to undergo surgery for resection of brain tumor.
- Patient medically not eligible to undergo craniotomy. (Medical contraindication).
- Patient has a medical contraindication or is unwilling to undergo MRI scanning
(pacemaker, other metal device ot parts in head or body,).
- Kidney function compromise (Creatinine values > 1.4 mg/dL).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary end point of the study is assessment and comparison of intra-operative Magnet Resonance Imaging and ultrasound to better define its impact on the extent of resection.
Outcome Time Frame:
72 hours
Safety Issue:
No
Principal Investigator
Andrew Kanner, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tel-Aviv Sorasky Medical Center
Authority:
Israel: Ethics Commission
Study ID:
TASMC-09-AK-0351
NCT ID:
NCT00977327
Start Date:
September 2009
Completion Date:
Related Keywords:
- Glioma
- Glioma
- Intraoperative MR
- Intraoperative Ultrasound
- resection
- Intraoperative navigation
- Extent of resection
- Brain Neoplasms
- Glioma