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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glioma

Intervention / Treatment
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* Device: Intraoperative MR (PoleStar N-20, Medtronics)
* Device: Intraoperative Ultrasound (Sonowand, Mison)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intraoperative MR<br>Use of intraoperative MR during resection of intraaxial tumor, Glioma | Device: Intraoperative MR (PoleStar N-20, Medtronics)<br>* intraoperative imaging for resection control of intraaxial brain lesions<br>* Other names: PoleStar N-20, Medtronics;|
| Other: Intraoperative Ultrasound<br>Use of intraoperative ultrasound during resection of intraaxial tumor, Glioma | Device: Intraoperative Ultrasound (Sonowand, Mison)<br>* intraoperative imaging for resection control of intraaxial brain lesions<br>* Other names: Sonowand, Mison;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioma, Intraoperative MR, Intraoperative Ultrasound, resection, Intraoperative navigation, Extent of resection