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

NCT ID: NCT00977327

Last Updated: 2009-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30

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.

Conditions

Glioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intraoperative MR

Use of intraoperative MR during resection of intraaxial tumor, Glioma

Group Type: OTHER

Intraoperative MR (PoleStar N-20, Medtronics)

Intervention Type: DEVICE

intraoperative imaging for resection control of intraaxial brain lesions

Intraoperative Ultrasound

Use of intraoperative ultrasound during resection of intraaxial tumor, Glioma

Group Type: OTHER

Intraoperative Ultrasound (Sonowand, Mison)

Intervention Type: DEVICE

intraoperative imaging for resection control of intraaxial brain lesions

Interventions

Intraoperative MR (PoleStar N-20, Medtronics)

intraoperative imaging for resection control of intraaxial brain lesions

Intervention Type: DEVICE

Intraoperative Ultrasound (Sonowand, Mison)

intraoperative imaging for resection control of intraaxial brain lesions

Intervention Type: DEVICE

Other Intervention Names

PoleStar N-20, Medtronics; Sonowand, Mison

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Department of Neurosurgery

Principal Investigators

Andrew Kanner, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sorasky Medical Center

Locations

Tel-Aviv Sorasky MC

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Andrew Kanner, MD

Role: CONTACT

andrewk@tasmc.health.gov.il

972-3-6974075

Carmit Ben Harosh, RN,MA

Role: CONTACT

carmitbh@tasmc.health.gov.il

972-3-6974397

Facility Contacts

Carmit Ben-Harosh, RN,MA

Role: primary

carmitbh@tasmc.health.gov.il

972-3-6974397

Other Identifiers

TASMC-09-AK-0351

Identifier Type: -

Identifier Source: org_study_id