Borderzone Sampling (BZS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780819
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : May 14, 2013
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
High Grade Glioma Glioblastoma Device: PoleStar N20 intraoperative MRI Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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?
Study Start Date : October 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : December 2012

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U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Postoperative clinical condition (WHO Performance Scale) [ Time Frame: 1 week after surgery ]
  3. Survival (Kaplan Meier) [ Time Frame: after 4 years ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Maastricht University Medical Center Identifier: NCT00780819     History of Changes
Other Study ID Numbers: MEC 07-2-039
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 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