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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00977327

Enrollment

120

Registered

2009-09-15

Start date

2009-09-30

Completion date

Unknown

Last updated

2009-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

Keywords

Glioma, Intraoperative MR, Intraoperative Ultrasound, resection, Intraoperative navigation, Extent of resection

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.

Interventions

DEVICEIntraoperative MR (PoleStar N-20, Medtronics)

intraoperative imaging for resection control of intraaxial brain lesions

DEVICEIntraoperative Ultrasound (Sonowand, Mison)

intraoperative imaging for resection control of intraaxial brain lesions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Israel

Contacts

Primary ContactAndrew Kanner, MD

andrewk@tasmc.health.gov.il972-3-6974075

Backup ContactCarmit Ben Harosh, RN,MA

carmitbh@tasmc.health.gov.il972-3-6974397

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026