Clinical trial · Interventional
Intraoperative MRI-guidance in Frameless Stereotactic Biopsies
The Safety and Effectiveness of Low Field Intraoperative MRI-guidance in Frameless Stereotactic Biopsies of Brain Tumours - a Prospective Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Primary investigator has changed his employee and the country of residence.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Brain Tumour | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iMRI-guided brain tumour biopsy | Device | — | UNRESOLVED |
| Stereotactic frameless brain tumour biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- iMRI-guided
- description
- 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.
- interventionNames
- Device: iMRI-guided brain tumour biopsy
- type
- ACTIVE_COMPARATOR
- label
- non-iMRI
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDShooman 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
- BACKGROUNDCzyz 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
- BACKGROUNDBernays 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
- BACKGROUNDWeaver 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
- BACKGROUNDFrati 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
- BACKGROUNDHan 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
- BACKGROUNDIsaacs 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.