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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00780819
Other study ID # MEC 07-2-039
Secondary ID ABR-17679
Status Completed
Phase N/A
First received October 27, 2008
Last updated May 13, 2013
Start date October 2008
Est. completion date December 2012

Study information

Verified date May 2013
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2012
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
PoleStar N20 intraoperative MRI
low field strength mobile intraoperative MRI system (0,15 Tesla) with local Faraday shielding (using the StarShield system)

Locations

Country Name City State
Netherlands Maastricht University Medical Center Maastricht Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. after surgery, and after 1 year for additional immunochemistry Yes
Secondary The relation between possible contrast enhancement and contrast enhancing tissue volume on the last intraoperative MRI scan and the early diagnostic MRI scan within 72 hours after surgery No
Secondary Postoperative clinical condition (WHO Performance Scale) 1 week after surgery Yes
Secondary Survival (Kaplan Meier) after 4 years No
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