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

Glioma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00977327
• Other study ID #: TASMC-09-AK-0351
• Status: Not yet recruiting
• Phase: N/A
• First received: August 30, 2009
• Last updated: September 14, 2009
• Start date: September 2009

Study information

• Verified date: September 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Andrew Kanner, MD
• Phone: 972-3-6974075
• Email: andrewk[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma

Intervention

Device:
• Intraoperative MR (PoleStar N-20, Medtronics)
intraoperative imaging for resection control of intraaxial brain lesions
• Intraoperative Ultrasound (Sonowand, Mison)
intraoperative imaging for resection control of intraaxial brain lesions

Locations

Country	Name	City	State
Israel	Tel-Aviv Sorasky MC	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary end points should identify criteria for selecting the right system for a specific patient (Patient selection), and cost-effectiveness.		3-6 months	No