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Borderzone Sampling (BZS)

This study has been completed.
Information provided by (Responsible Party):
Maastricht University Medical Center Identifier:
First received: October 27, 2008
Last updated: May 13, 2013
Last verified: May 2013
On regular (diagnostic) MRI images brain tumors can show "contrast enhancement": uptake of an intravenously administered contrast agent can cause an enhancement pattern that is seen as a white area on a frequently used MRI protocol ("T1 weighted imaging"). High grade gliomas are a common brain tumor that share this enhancement pattern. The goal of surgery is to resect this contrast enhancing part without causing additional neurological damage. Intraoperative MRI (iMRI) is a helpful tool in achieving this goal, because it can provide updated images during resection and correct for deformations that occur in the brain during surgery. These deformations make preoperative images that are used for standard neuronavigation systems less reliable. However, due to manipulations during surgery, the contrast uptake during surgery may differ from contrast uptake in diagnostic MRI. This study aims to relate contrast enhancement on iMRI and tumor characteristics on tissue samples from the tumor. When the neurosurgeon considers the resection of the high grade glioma to be complete, an iMRI scan will be made, and tissue sampling will be performed on the borderzones of the tumor or tumor resection cavity respectively. This will provide insight in the relation between contrast enhancement on iMRI and the presence of tumor tissue. Such knowledge is important to improve effectiveness and safety of iMRI guided brain tumor resection.

Condition Intervention
High Grade Glioma Glioblastoma Device: PoleStar N20 intraoperative MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Does Borderzone Contrast Enhancement on Intraoperative MRI During High Grade Glioma Resection Correlate With Residual Tumor?

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • The relation between the shape and size of contrast enhancement on intraoperative MRI at the resection cavity border, and the presence of residual tumor tissue. [ Time Frame: after surgery, and after 1 year for additional immunochemistry ]

Secondary Outcome Measures:
  • The relation between possible contrast enhancement and contrast enhancing tissue volume on the last intraoperative MRI scan and the early diagnostic MRI scan [ Time Frame: within 72 hours after surgery ]
  • Postoperative clinical condition (WHO Performance Scale) [ Time Frame: 1 week after surgery ]
  • Survival (Kaplan Meier) [ Time Frame: after 4 years ]

Enrollment: 10
Study Start Date: October 2008
Study Completion Date: December 2012
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PoleStar N20 intraoperative MRI
PoleStar N20 intraoperative MRI
Device: PoleStar N20 intraoperative MRI
low field strength mobile intraoperative MRI system (0,15 Tesla) with local Faraday shielding (using the StarShield system)
Other Name: manufactured by Odin Medical Technologies (Yokneam, Israel), incorporated in Medtronic Navigation (Louisville, CO; USA)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • supratentorial brain tumor, on contrast enhanced MRI suspect for a high grade glioma
  • indication for resection of the tumor
  • age ≥ 18 years
  • WHO Performance Scale ≤ 2
  • ASA class ≤ 3
  • good knowledge of the Dutch language
  • informed consent

Exclusion Criteria:

  • recurrent tumor
  • multiple tumor localizations
  • prior radiotherapy on the skull
  • prior chemotherapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00780819

Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Principal Investigator: Pieter L Kubben, MD Maastricht University Medical Center
  More Information

Responsible Party: Maastricht University Medical Center Identifier: NCT00780819     History of Changes
Other Study ID Numbers: MEC 07-2-039
Study First Received: October 27, 2008
Last Updated: May 13, 2013

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue processed this record on September 21, 2017