Borderzone Sampling

Glioblastoma Clinical Trial

— BZS  

Official title:

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

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

• Glioblastoma
• High Grade Glioma

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