Intraoperative MRI-guidance in Frameless Stereotactic Biopsies

NCT01779219 | Terminated Results

• 1 other identifier: STAT2009
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Brain Tumour

Keywords

intraoperative magnetic resonance; stereotactic biopsy; brain tumor; frameless stereotaxy; image-guided neurosurgery

Outcome Measures

Primary Outcomes (2)

• Number of Participants Presenting With Complications

  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.

  Patients were followed for the duration of hospital stay (average 2 days) and again 2 weeks after the operation.

• Diagnostic Yield

  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.

  For each patient 2 weeks after the operation

Secondary Outcomes (2)

• Length of Hospital Stay

  From date of hospitalization until the date of discharge, assessed up to 2 days.

• Time

  From moment of the transfer to the OR until the moment of transfer out of it, assessed on the day of operation.

Study Arms (2)

iMRI-guided

ACTIVE COMPARATOR

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

non-iMRI

ACTIVE COMPARATOR

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

Interventions

iMRI-guided brain tumour biopsy DEVICE

The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet was used in all procedures.

Also known as: iMRI

iMRI-guided

Stereotactic frameless brain tumour biopsy DEVICE

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).

Also known as: Neuronavigation, Non-iMRI

non-iMRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients unable to provide informed consent
• metal implants which could prevent or influence the head MR study

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Department of Neurosurgery, Wroclaw Medical University

Wroclaw, 50-556, Poland

Location

Related Publications (13)

• Shooman D, Belli A, Grundy PL. Image-guided frameless stereotactic biopsy without intraoperative neuropathological examination. J Neurosurg. 2010 Aug;113(2):170-8. doi: 10.3171/2009.12.JNS09573.

  PMID: 20136389 BACKGROUND

• Czyz M, Tabakow P, Jarmundowicz W, Lechowicz-Glogowska B. Intraoperative magnetic resonance-guided frameless stereotactic biopsies - initial clinical experience. Neurol Neurochir Pol. 2012 Mar-Apr;46(2):157-60. doi: 10.5114/ninp.2012.28258.

  PMID: 22581597 BACKGROUND

• Bernays RL, Kollias SS, Khan N, Brandner S, Meier S, Yonekawa Y. Histological yield, complications, and technological considerations in 114 consecutive frameless stereotactic biopsy procedures aided by open intraoperative magnetic resonance imaging. J Neurosurg. 2002 Aug;97(2):354-62. doi: 10.3171/jns.2002.97.2.0354.

  PMID: 12186464 BACKGROUND

• Weaver CS, Leonardi-Bee J, Bath-Hextall FJ, Bath PM. Sample size calculations in acute stroke trials: a systematic review of their reporting, characteristics, and relationship with outcome. Stroke. 2004 May;35(5):1216-24. doi: 10.1161/01.STR.0000125010.70652.93. Epub 2004 Mar 18.

  PMID: 15031455 BACKGROUND

• Frati A, Pichierri A, Bastianello S, Raco A, Santoro A, Esposito V, Giangaspero F, Salvati M. Frameless stereotactic cerebral biopsy: our experience in 296 cases. Stereotact Funct Neurosurg. 2011;89(4):234-45. doi: 10.1159/000325704. Epub 2011 Jul 21.

  PMID: 21778794 BACKGROUND

• Han B, Enas NH, McEntegart D. Randomization by minimization for unbalanced treatment allocation. Stat Med. 2009 Nov 30;28(27):3329-46. doi: 10.1002/sim.3710.

  PMID: 19739238 BACKGROUND

• Isaacs D, Fitzgerald D. Seven alternatives to evidence based medicine. BMJ. 1999 Dec 18-25;319(7225):1618. doi: 10.1136/bmj.319.7225.1618. No abstract available.

  PMID: 10600968 BACKGROUND

• Kundt G. Comparative evaluation of balancing properties of stratified randomization procedures. Methods Inf Med. 2009;48(2):129-34. doi: 10.3414/ME0538. Epub 2009 Feb 18.

  PMID: 19283309 BACKGROUND

• Langen HJ, Kugel H, Ortmann M, Noack M, de Rochemont RM, Landwehr P. [Functional capacity of MRI-compatible biopsy needles in comparison with ferromagnetic biopsy needles. In vitro studies]. Rofo. 2001 Jul;173(7):658-62. doi: 10.1055/s-2001-15844. German.

  PMID: 11512240 BACKGROUND

• McGirt MJ, Woodworth GF, Coon AL, Frazier JM, Amundson E, Garonzik I, Olivi A, Weingart JD. Independent predictors of morbidity after image-guided stereotactic brain biopsy: a risk assessment of 270 cases. J Neurosurg. 2005 May;102(5):897-901. doi: 10.3171/jns.2005.102.5.0897.

  PMID: 15926716 BACKGROUND

• Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

  PMID: 7165009 BACKGROUND

• Schulder M, Spiro D. Intraoperative MRI for stereotactic biopsy. Acta Neurochir Suppl. 2011;109:81-7. doi: 10.1007/978-3-211-99651-5_13.

  PMID: 20960325 BACKGROUND

• Senft C, Bink A, Franz K, Vatter H, Gasser T, Seifert V. Intraoperative MRI guidance and extent of resection in glioma surgery: a randomised, controlled trial. Lancet Oncol. 2011 Oct;12(11):997-1003. doi: 10.1016/S1470-2045(11)70196-6. Epub 2011 Aug 23.

  PMID: 21868284 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Neuronavigation

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Surgery, Computer-Assisted; Investigative Techniques

Results Point of Contact

• Title: Dr. Marcin Czyz
• Organization: Wroclaw University Hospital, Department of Neurosurgery

mt.czyz@gmail.com

+48 734-34-00

Study Officials

• Wlodzimierz Jarmundowicz, Professor

  Wroclaw Medical University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 30, 2013
• Study Start: June 1, 2009
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 15, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-01

Locations

PL (1)