search
Back to results

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
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for High Grade Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 27, 2008
Last Updated
May 13, 2013
Sponsor
Maastricht University Medical Center
search

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

We'll reach out to this number within 24 hrs