Borderzone Sampling

NCT00780819 | Completed DMC

• 2 other identifiers: MEC 07-2-039ABR-17679
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

High Grade Glioma; Glioblastoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Postoperative clinical condition (WHO Performance Scale)

  1 week after surgery

• Survival (Kaplan Meier)

  after 4 years

Study Arms (1)

PoleStar N20 intraoperative MRI

EXPERIMENTAL

PoleStar N20 intraoperative MRI

Device: PoleStar N20 intraoperative MRI

Interventions

PoleStar N20 intraoperative MRI DEVICE

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

Also known as: manufactured by Odin Medical Technologies (Yokneam, Israel), incorporated in Medtronic Navigation (Louisville, CO; USA)

PoleStar N20 intraoperative MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• recurrent tumor
• multiple tumor localizations
• prior radiotherapy on the skull
• prior chemotherapy

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Study Officials

• Pieter L Kubben, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 28, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2012
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

NL (1)