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

Not Applicable

• Conditions: Glioma
• Interventions: Device: Intraoperative MR (PoleStar N-20, Medtronics); Device: Intraoperative Ultrasound (Sonowand, Mison)

• Registration Number: NCT00977327
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-30
• Status Verified: 2009-09
• Study Start: 2009-09
• Study First Submitted QC: 2009-09-14
• Last Update Submitted: 2009-09-14
• Study First Posted: 2009-09-15
• Last Update Posted: 2009-09-15
• Primary Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraoperative MR	Intraoperative MR (PoleStar N-20, Medtronics)	Use of intraoperative MR during resection of intraaxial tumor, Glioma
Intraoperative Ultrasound	Intraoperative Ultrasound (Sonowand, Mison)	Use of intraoperative ultrasound during resection of intraaxial tumor, Glioma

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Tel-Aviv Sorasky MC; 🇮🇱 Tel-Aviv, Israel