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BZS: Borderzone Sampling

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00780819
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
50
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: PoleStar N20 intraoperative MRI
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
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 :
Oct 1, 2008
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

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 Names:
  • manufactured by Odin Medical Technologies (Yokneam, Israel), incorporated in Medtronic Navigation (Louisville, CO; USA)

    		•

    Outcome Measures

    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. [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 [within 72 hours after surgery]

    2. Postoperative clinical condition (WHO Performance Scale) [1 week after surgery]

    3. Survival (Kaplan Meier) [after 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Maastricht University Medical Center Maastricht Limburg Netherlands 6202 AZ

    Sponsors and Collaborators

    • Maastricht University Medical Center

    Investigators

    • Principal Investigator: Pieter L Kubben, MD, Maastricht University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT00780819
    Other Study ID Numbers:
    • MEC 07-2-039
    • ABR-17679
    First Posted:
    Oct 28, 2008
    Last Update Posted:
    May 14, 2013
    Last Verified:
    May 1, 2013
    Additional relevant MeSH terms:
    Glioblastoma
    Glioma

    Study Results

    No Results Posted as of May 14, 2013