MedTrace Logo

Borderzone Sampling

NCT00780819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-05-14

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

PoleStar N20 intraoperative MRI

low field strength mobile intraoperative MRI system (0,15 Tesla) with local Faraday shielding (using the StarShield system)

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Pieter L Kubben, MD · Maastricht University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-07-31
Completion
2012-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00780819 on ClinicalTrials.gov