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

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00977327

Collaborator

(none)

120

Enrollment

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma	Device: Intraoperative MR (PoleStar N-20, Medtronics) Device: Intraoperative Ultrasound (Sonowand, Mison)	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2009

Anticipated Primary Completion Date :

May 1, 2011

Arms and Interventions

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

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

Outcome Measures

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. [72 hours]

Secondary Outcome Measures

Secondary end points should identify criteria for selecting the right system for a specific patient (Patient selection), and cost-effectiveness. [3-6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).