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Sponsored by: |
Maastricht University Medical Center |
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Information provided by: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00780819 |
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 | Intervention |
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High Grade Glioma Glioblastoma |
Device: PoleStar N20 intraoperative MRI |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Does Borderzone Contrast Enhancement on Intraoperative MRI During High Grade Glioma Resection Correlate With Residual Tumor? |
Estimated Enrollment: | 10 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pieter L Kubben, MD | +31 (43) 3876052 | pieter@kubben.nl |
Contact: Henk van Santbrink, MD, PhD | +31 (43) 3874041 | h.van.santbrink@mumc.nl |
Netherlands, Limburg | |
Maastricht University Medical Center | Recruiting |
Maastricht, Limburg, Netherlands, 6202 AZ | |
Contact: Pieter L Kubben, MD +31 (43) 3876052 pieter@kubben.nl | |
Contact: Henk van Santbrink, MD, PhD +31 (43) 3874041 h.van.santbrink@mumc.nl | |
Principal Investigator: Henk van Santbrink, MD, PhD | |
Sub-Investigator: Pieter L Kubben, MD |
Principal Investigator: | Pieter L Kubben, MD | Maastricht University Medical Center |
Responsible Party: | Maastricht University Medical Center ( H van Santbrink, MD, PhD ) |
Study ID Numbers: | MEC 07-2-039, ABR-17679 |
Study First Received: | October 27, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00780819 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Neuroectodermal Tumors Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |