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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


N/A
18 Years
N/A
Not Enrolling
Both
Glioma

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Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

72 hours

Safety Issue:

No

Principal Investigator

Andrew Kanner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tel-Aviv Sorasky Medical Center

Authority:

Israel: Ethics Commission

Study ID:

TASMC-09-AK-0351

NCT ID:

NCT00977327

Start Date:

September 2009

Completion Date:

Related Keywords:

  • Glioma
  • Glioma
  • Intraoperative MR
  • Intraoperative Ultrasound
  • resection
  • Intraoperative navigation
  • Extent of resection
  • Brain Neoplasms
  • Glioma

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