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

September 14, 2009 updated by: Tel-Aviv Sourasky Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel, 64239
        • Tel-Aviv Sorasky MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • PoleStar N-20, Medtronics
Other: 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 Names:
  • Sonowand, Mison

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Andrew Kanner, MD, Tel-Aviv Sorasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

August 30, 2009

First Submitted That Met QC Criteria

September 14, 2009

First Posted (Estimate)

September 15, 2009

Study Record Updates

Last Update Posted (Estimate)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-09-AK-0351

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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