Intraoperative MRI-guidance in Frameless Stereotactic Biopsies

This study has been terminated.
(Primary investigator has changed his employee and the country of residence.)
Sponsor:
Information provided by (Responsible Party):
Marcin Czyz, Wroclaw Medical University
ClinicalTrials.gov Identifier:
NCT01779219
First received: January 15, 2013
Last updated: January 17, 2016
Last verified: January 2016
  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
Primary Brain Tumour
Device: iMRI-guided 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:
  • Number of Participants Presenting With Complications [ Time Frame: Patients were followed for the duration of hospital stay (average 2 days) 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 as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the operation.


Secondary Outcome Measures:
  • Length of Hospital Stay [ Time Frame: From date of hospitalization until the date of discharge, assessed up to 2 days. ] [ Designated as safety issue: No ]
    The preoperative (LOSpre), postoperative (LOSpost) and total length of hospital stay (LOS)

  • Time [ Time Frame: From moment of the transfer to the OR until the moment of transfer out of it, assessed on the day of operation. ] [ Designated as safety issue: No ]
    the preparation (Tprep), operation (Top) and total operating room (TOR) time


Enrollment: 42
Study Start Date: June 2009
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: iMRI-guided
Intervention: iMRI-guided brain tumour biopsy. The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet imager will be used in all cases. After the patient's positioning, the preoperative reference examination is routinely carried out. 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 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: iMRI-guided 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
Intervention: Stereotactic frameless brain tumour biopsy. 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779219

Locations
Poland
Department of Neurosurgery, Wroclaw Medical University
Wroclaw, Poland, 50-556
Sponsors and Collaborators
Wroclaw Medical University
Investigators
Study Chair: Wlodzimierz Jarmundowicz, Professor 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
Results First Received: June 3, 2015
Last Updated: January 17, 2016
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 July 24, 2016