Comparison of Neuro-navigational Systems for Resection-Control of Brain Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: August 30, 2009
Last updated: September 14, 2009
Last verified: September 2009


  • Improvement of extent of resection by the use of intraoperatively acquired image data sets to navigate.
  • Better define the role of different intra-operative imaging modalities, used to update the navigational data set, in aiding the surgeon during resection of intra-axial brain lesions.
  • To examine the cost-effectiveness of different intraoperative navigational systems as a function of operative time and Operative time (Surgery including imaging)

There is increasing neuro-oncological evidence that extent of resection might have an impact in particular in low-grade lesions.

Condition Intervention
Device: Intraoperative MR (PoleStar N-20, Medtronics)
Device: Intraoperative Ultrasound (Sonowand, Mison)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary end points should identify criteria for selecting the right system for a specific patient (Patient selection), and cost-effectiveness. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intraoperative MR
Use of intraoperative MR during resection of intraaxial tumor, Glioma
Device: Intraoperative MR (PoleStar N-20, Medtronics)
intraoperative imaging for resection control of intraaxial brain lesions
Other Name: PoleStar N-20, Medtronics
Intraoperative Ultrasound
Use of intraoperative ultrasound during resection of intraaxial tumor, Glioma
Device: Intraoperative Ultrasound (Sonowand, Mison)
intraoperative imaging for resection control of intraaxial brain lesions
Other Name: Sonowand, Mison


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00977327

Contact: Andrew Kanner, MD 972-3-6974075
Contact: Carmit Ben Harosh, RN,MA 972-3-6974397

Tel-Aviv Sorasky MC Not yet recruiting
Tel-Aviv, Israel, 64239
Contact: Carmit Ben-Harosh, RN,MA    972-3-6974397   
Principal Investigator: Andrew Kanner, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Andrew Kanner, MD Tel-Aviv Sorasky Medical Center
  More Information

No publications provided

Responsible Party: Andrew Kanner MD, Department of Neurosurgery Identifier: NCT00977327     History of Changes
Other Study ID Numbers: TASMC-09-AK-0351 
Study First Received: August 30, 2009
Last Updated: September 14, 2009
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
Intraoperative MR
Intraoperative Ultrasound
Intraoperative navigation
Extent of resection processed this record on February 11, 2016