iMRI-guided Brain Biopsies

This study is currently recruiting participants.
Verified January 2013 by Wroclaw Medical University
Sponsor:
Information provided by (Responsible Party):
Marcin Czyz, Wroclaw Medical University
ClinicalTrials.gov Identifier:
NCT01779219
First received: January 15, 2013
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

Background: The aim of the study was to assess the safety and effectiveness of stereotactic brain tumour biopsy (STx biopsy) guided by low-field intraoperative MRI (iMRI) in comparison with its frameless classic analogue based on a prospective randomized trial.

Patients are prospectively randomized into a low-field iMRI group and a control group that undergo a frameless STx biopsy. The primary endpoints of the analysis are: postoperative complication rate and diagnostic yield, and the secondary endpoints: length of hospital stay and duration of operation.


Condition Intervention
Supratentorial Brain Tumour
Device: Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy
Device: Stereotactic frameless brain tumour biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Safety and Effectiveness of Low Field Intraoperative MRI-guidance in Frameless Stereotactic Biopsies of Brain Tumours - a Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Wroclaw Medical University:

Primary Outcome Measures:
  • Complications ratio [ Time Frame: Patients will be followed for the duration of hospital stay and again 2 weeks after the operation ] [ Designated as safety issue: Yes ]
    The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the operation, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological or clinical signs of the intracranial expansion.

  • Diagnostic yield [ Time Frame: For each patient 2 weeks after the operation ] [ Designated as safety issue: No ]
    The diagnostic yield is expressed according to the literature as a percentage of patients in whom the histopathological diagnosis was possible on the basis of the biological material obtained during the operation.


Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: LOSpre will be assessed on the day of the operation; LOSpost and LOS will be calculated at discharge from the hospital - in average 1 day after the surgery ] [ Designated as safety issue: No ]
    The preoperative (LOSpre), postoperative (LOSpost) and total length of hospital stay (LOS)

  • Time [ Time Frame: For each patient on the day of the operation (day 1) ] [ Designated as safety issue: No ]
    The preparation (Tprep), operation (Top) and total operating room (TOR) time


Estimated Enrollment: 200
Study Start Date: June 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: iMRI
The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Device: Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy
The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet was used in all procedures.
Other Name: iMRI
Active Comparator: non-iMRI
A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Device: Stereotactic frameless brain tumour biopsy
The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Other Names:
  • Neuronavigation
  • Non-iMRI

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female patients ≥ 18 years
  • supratentorial brain tumour
  • scheduled to undergo STx biopsy

Exclusion Criteria:

  • patients unable to provide informed consent
  • metal implants which could prevent or influence the head MR study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779219

Contacts
Contact: Marcin Czyż, MD, PhD 504150014 mt.czyz@gmail.com

Locations
Poland
Department of Neurosurgery, Wroclaw Medical University Recruiting
Wroclaw, Poland, 50-556
Contact: Marcin Czyż, MD, PhD    +48504150014    mt.czyz@gmail.com   
Principal Investigator: Marcin Czyż, MD, PhD         
Sub-Investigator: Paweł Tabakow, MD, PhD         
Sub-Investigator: Artur Weiser, MD, PhD         
Sub-Investigator: Wojciech L Zub, MD, PhD         
Sub-Investigator: Włodzimierz Jarmundowicz, Professor         
Sponsors and Collaborators
Wroclaw Medical University
  More Information

Publications:

Responsible Party: Marcin Czyz, M.D., Ph.D., Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT01779219     History of Changes
Other Study ID Numbers: STAT2009
Study First Received: January 15, 2013
Last Updated: January 29, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Wroclaw Medical University:
intraoperative magnetic resonance
stereotactic biopsy
brain tumor
frameless stereotaxy
image-guided neurosurgery

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014