NCT00977327

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

1.7 years

First QC Date

August 30, 2009

Last Update Submit

September 14, 2009

Conditions

Glioma

Keywords

GliomaIntraoperative MRIntraoperative UltrasoundresectionIntraoperative navigationExtent of resection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Secondary end points should identify criteria for selecting the right system for a specific patient (Patient selection), and cost-effectiveness.

    3-6 months

Study Arms (2)

Intraoperative MR

OTHER

Use of intraoperative MR during resection of intraaxial tumor, Glioma

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

Intraoperative Ultrasound

OTHER

Use of intraoperative ultrasound during resection of intraaxial tumor, Glioma

Device: Intraoperative Ultrasound (Sonowand, Mison)

Interventions

Intraoperative MR (PoleStar N-20, Medtronics)DEVICE

intraoperative imaging for resection control of intraaxial brain lesions

Also known as: PoleStar N-20, Medtronics
Intraoperative MR
Intraoperative Ultrasound (Sonowand, Mison)DEVICE

intraoperative imaging for resection control of intraaxial brain lesions

Also known as: Sonowand, Mison
Intraoperative Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sorasky MC

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Andrew Kanner, MD

    Tel-Aviv Sorasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Kanner, MD

CONTACT

972-3-6974075andrewk@tasmc.health.gov.il

Carmit Ben Harosh, RN,MA

CONTACT

972-3-6974397carmitbh@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 30, 2009

First Posted

September 15, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2011

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

IL(1)