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
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00977327
First received: August 30, 2009
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

Purpose:

  • 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
Glioma
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

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977327

Contacts
Contact: Andrew Kanner, MD 972-3-6974075 andrewk@tasmc.health.gov.il
Contact: Carmit Ben Harosh, RN,MA 972-3-6974397 carmitbh@tasmc.health.gov.il

Locations
Israel
Tel-Aviv Sorasky MC Not yet recruiting
Tel-Aviv, Israel, 64239
Contact: Carmit Ben-Harosh, RN,MA    972-3-6974397    carmitbh@tasmc.health.gov.il   
Principal Investigator: Andrew Kanner, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Andrew Kanner, MD Tel-Aviv Sorasky Medical Center
  More Information

No publications provided

Responsible Party: Andrew Kanner MD, Department of Neurosurgery
ClinicalTrials.gov 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:
Glioma
Intraoperative MR
Intraoperative Ultrasound
resection
Intraoperative navigation
Extent of resection

ClinicalTrials.gov processed this record on September 30, 2014