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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Glioma

Treatments: Device: Intraoperative MR (PoleStar N-20, Medtronics); Device: Intraoperative Ultrasound (Sonowand, Mison)

Study type: Interventional

Funder types: Other

Identifiers

NCT00977327

TASMC-09-AK-0351

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intraoperative MR

Other group

Description:

Use of intraoperative MR during resection of intraaxial tumor, Glioma

Treatment:

Device: Intraoperative MR (PoleStar N-20, Medtronics)

Intraoperative Ultrasound

Other group

Description:

Use of intraoperative ultrasound during resection of intraaxial tumor, Glioma

Treatment:

Device: Intraoperative Ultrasound (Sonowand, Mison)