Borderzone Sampling (BZS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00780819
First received: October 27, 2008
Last updated: May 13, 2013
Last verified: May 2013

October 27, 2008
May 13, 2013
October 2008
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00780819 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Postoperative clinical condition (WHO Performance Scale) [ Time Frame: 1 week after surgery ] [ Designated as safety issue: Yes ]
  • Survival (Kaplan Meier) [ Time Frame: after 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Borderzone Sampling
Does Borderzone Contrast Enhancement on Intraoperative MRI During High Grade Glioma Resection Correlate With Residual Tumor?

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • High Grade Glioma
  • Glioblastoma
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)
Experimental: PoleStar N20 intraoperative MRI
PoleStar N20 intraoperative MRI
Intervention: Device: PoleStar N20 intraoperative MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2012
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00780819
MEC 07-2-039, ABR-17679
Yes
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Pieter L Kubben, MD Maastricht University Medical Center
Maastricht University Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP