iMRI-guided Brain Biopsies
This study is currently recruiting participants.
Verified January 2013 by Wroclaw Medical University
Sponsor:
Wroclaw Medical University
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
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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:
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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 May 23, 2013