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

Tel-Aviv Sourasky Medical Center120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Glioma

Interventions

Intraoperative MR (PoleStar N-20, Medtronics)DEVICE

intraoperative imaging for resection control of intraaxial brain lesions

Intraoperative Ultrasound (Sonowand, Mison)DEVICE

intraoperative imaging for resection control of intraaxial brain lesions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Tel-Aviv Sorasky MC

Tel Aviv, Israel

Outcomes

Primary Outcomes

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 Outcomes

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

Central Contacts

Andrew Kanner, MD

CONTACT

972-3-6974075 andrewk@tasmc.health.gov.il

Carmit Ben Harosh, RN,MA

CONTACT

972-3-6974397 carmitbh@tasmc.health.gov.il

Data from ClinicalTrials.gov

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