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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00977327
Other study ID # TASMC-09-AK-0351
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 30, 2009
Last updated September 14, 2009
Start date September 2009

Study information

Verified date September 2009
Source Tel-Aviv Sourasky Medical Center
Contact Andrew Kanner, MD
Phone 972-3-6974075
Email andrewk@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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).

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
Intraoperative MR (PoleStar N-20, Medtronics)
intraoperative imaging for resection control of intraaxial brain lesions
Intraoperative Ultrasound (Sonowand, Mison)
intraoperative imaging for resection control of intraaxial brain lesions

Locations

Country Name City State
Israel Tel-Aviv Sorasky MC Tel-Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Secondary end points should identify criteria for selecting the right system for a specific patient (Patient selection), and cost-effectiveness. 3-6 months No
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