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

Primary Purpose

Glioma

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Intraoperative MR (PoleStar N-20, Medtronics)

Intraoperative Ultrasound (Sonowand, Mison)

About this trial

This is an interventional treatment trial for Glioma focused on measuring Glioma, Intraoperative MR, Intraoperative Ultrasound, resection, Intraoperative navigation, Extent of resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Tel-Aviv Sorasky MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Intraoperative MR

Intraoperative Ultrasound

Arm Description

Use of intraoperative MR during resection of intraaxial tumor, Glioma

Use of intraoperative ultrasound during resection of intraaxial tumor, Glioma

Outcomes

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.

Secondary Outcome Measures

Secondary end points should identify criteria for selecting the right system for a specific patient (Patient selection), and cost-effectiveness.

Full Information

NCT ID

NCT00977327

First Posted

August 30, 2009

Last Updated

September 14, 2009

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00977327

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

May 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma

Keywords

Glioma, Intraoperative MR, Intraoperative Ultrasound, resection, Intraoperative navigation, Extent of resection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intraoperative MR

Arm Type

Other

Arm Description

Use of intraoperative MR during resection of intraaxial tumor, Glioma

Arm Title

Intraoperative Ultrasound

Arm Type

Other

Arm Description

Use of intraoperative ultrasound during resection of intraaxial tumor, Glioma

Intervention Type

Device

Intervention Name(s)

Intraoperative MR (PoleStar N-20, Medtronics)

Other Intervention Name(s)

PoleStar N-20, Medtronics

Intervention Description

intraoperative imaging for resection control of intraaxial brain lesions

Intervention Type

Device

Intervention Name(s)

Intraoperative Ultrasound (Sonowand, Mison)

Other Intervention Name(s)

Sonowand, Mison

Intervention Description

intraoperative imaging for resection control of intraaxial brain lesions

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrew Kanner, MD

Phone

972-3-6974075

andrewk@tasmc.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Carmit Ben Harosh, RN,MA

Phone

972-3-6974397

carmitbh@tasmc.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Kanner, MD

Organizational Affiliation

Tel-Aviv Sorasky Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tel-Aviv Sorasky MC

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carmit Ben-Harosh, RN,MA

Phone

972-3-6974397

carmitbh@tasmc.health.gov.il

First Name & Middle Initial & Last Name & Degree

Andrew Kanner, MD

12. IPD Sharing Statement

Learn more about this trial

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

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