Comparison of Neuro-navigational Systems for Resection-Control of Brain Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Tel-Aviv Sourasky Medical Center
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00977327
First received: August 30, 2009
Last updated: September 14, 2009
Last verified: September 2009
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Purpose
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 | Intervention |
|---|---|
|
Glioma |
Device: Intraoperative MR (PoleStar N-20, Medtronics) Device: Intraoperative Ultrasound (Sonowand, Mison) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Tel-Aviv Sourasky Medical Center:
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. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: PoleStar N-20, Medtronics
|
|
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 Name: Sonowand, Mison
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977327
Contacts
| Contact: Andrew Kanner, MD | 972-3-6974075 | andrewk@tasmc.health.gov.il |
| Contact: Carmit Ben Harosh, RN,MA | 972-3-6974397 | carmitbh@tasmc.health.gov.il |
Locations
| Israel | |
| Tel-Aviv Sorasky MC | Not yet recruiting |
| Tel-Aviv, Israel, 64239 | |
| Contact: Carmit Ben-Harosh, RN,MA 972-3-6974397 carmitbh@tasmc.health.gov.il | |
| Principal Investigator: Andrew Kanner, MD | |
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
| Principal Investigator: | Andrew Kanner, MD | Tel-Aviv Sorasky Medical Center |
More Information
No publications provided
| Responsible Party: | Andrew Kanner MD, Department of Neurosurgery |
| ClinicalTrials.gov Identifier: | NCT00977327 History of Changes |
| Other Study ID Numbers: | TASMC-09-AK-0351 |
| Study First Received: | August 30, 2009 |
| Last Updated: | September 14, 2009 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Glioma Intraoperative MR Intraoperative Ultrasound |
resection Intraoperative navigation Extent of resection |
Additional relevant MeSH terms:
|
Brain Neoplasms Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on June 17, 2013