Borderzone Sampling (BZS)
Primary Purpose
High Grade Glioma, Glioblastoma
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PoleStar N20 intraoperative MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for High Grade Glioma
Eligibility Criteria
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
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PoleStar N20 intraoperative MRI
Arm Description
PoleStar N20 intraoperative MRI
Outcomes
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.
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
Postoperative clinical condition (WHO Performance Scale)
Survival (Kaplan Meier)
Full Information
NCT ID
NCT00780819
First Posted
October 27, 2008
Last Updated
May 13, 2013
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00780819
Brief Title
Borderzone Sampling
Acronym
BZS
Official Title
Does Borderzone Contrast Enhancement on Intraoperative MRI During High Grade Glioma Resection Correlate With Residual Tumor?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Grade Glioma, Glioblastoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PoleStar N20 intraoperative MRI
Arm Type
Experimental
Arm Description
PoleStar N20 intraoperative MRI
Intervention Type
Device
Intervention Name(s)
PoleStar N20 intraoperative MRI
Other Intervention Name(s)
manufactured by Odin Medical Technologies (Yokneam, Israel), incorporated in Medtronic Navigation (Louisville, CO; USA)
Intervention Description
low field strength mobile intraoperative MRI system (0,15 Tesla) with local Faraday shielding (using the StarShield system)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Postoperative clinical condition (WHO Performance Scale)
Time Frame
1 week after surgery
Title
Survival (Kaplan Meier)
Time Frame
after 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter L Kubben, MD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Borderzone Sampling
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