Clinical Trials Directory

Trials / Completed

CompletedNCT00780819

Borderzone Sampling

Does Borderzone Contrast Enhancement on Intraoperative MRI During High Grade Glioma Resection Correlate With Residual Tumor?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Maastricht University Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DEVICEPoleStar N20 intraoperative MRIlow field strength mobile intraoperative MRI system (0,15 Tesla) with local Faraday shielding (using the StarShield system)

Timeline

Start date
2008-10-01
Primary completion
2009-07-01
Completion
2012-12-01
First posted
2008-10-28
Last updated
2013-05-14

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT00780819. Inclusion in this directory is not an endorsement.