COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00977327
Recruitment Status : Unknown
Verified September 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 15, 2009
Last Update Posted : September 15, 2009
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:


  • 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 or disease Intervention/treatment Phase
Glioma Device: Intraoperative MR (PoleStar N-20, Medtronics) Device: Intraoperative Ultrasound (Sonowand, Mison) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2009
Estimated Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00977327

Layout table for location contacts
Contact: Andrew Kanner, MD 972-3-6974075
Contact: Carmit Ben Harosh, RN,MA 972-3-6974397

Layout table for location information
Tel-Aviv Sorasky MC
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
Layout table for investigator information
Principal Investigator: Andrew Kanner, MD Tel-Aviv Sorasky Medical Center
Layout table for additonal information
Responsible Party: Andrew Kanner MD, Department of Neurosurgery Identifier: NCT00977327    
Other Study ID Numbers: TASMC-09-AK-0351
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009
Keywords provided by Tel-Aviv Sourasky Medical Center:
Intraoperative MR
Intraoperative Ultrasound
Intraoperative navigation
Extent of resection
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases