NCT00943007

Brief Summary

The treatment of a specific subtype of highly malignant brain tumor (called "glioblastoma" or "glioblastoma multiforme") consists of neurosurgical resection, followed by radiotherapy and mostly chemotherapy as well. Increased extent of tumor resection is associated with prolonged survival. The standard treatment uses conventional neuronavigation systems to increase extent of tumor resection. However, the quality of this form of neuronavigation decreases throughout surgery because of "brain shift". This is caused by edema, loss of cerebrospinal fluid and tumor resection. A new form of neuronavigation uses intraoperative MRI to compensate for brain shift, and to check for the presence of residual tumor that can be removed. This study aims to compare the extent of glioblastoma resection between the standard treatment and intraoperative MRI.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

3.3 years

First QC Date

July 20, 2009

Last Update Submit

April 9, 2015

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

  • Difference in Residual tumor volume

    <72h after surgery

Secondary Outcomes (2)

  • Complications, Clinical Performance, and Quality of Life

    3 months after surgery

  • Survival

    2 years after surgery

Study Arms (2)

Conventional Neuronavigation

ACTIVE COMPARATOR

Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift

Device: Stealth Station

Intraoperative MRI

EXPERIMENTAL

Standard neuronavigation plus intraoperative MRI to correct for brain shift

Device: PoleStar N20

Interventions

Stealth StationDEVICE

Neuronavigation based on preoperative MRI

Also known as: cNN
Conventional Neuronavigation
PoleStar N20DEVICE

Intraoperative MRI guided surgery

Also known as: iMRI
Intraoperative MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • supratentorial brain tumor, on contrast enhanced dMRI suspected to be GBM
  • indication for gross total resection (GTR) of the tumor
  • age ≥18 years
  • WHO Performance Scale ≤ 2
  • ASA class ≤ 3
  • adequate knowledge of the Dutch or French language
  • informed consent

You may not qualify if:

  • recurrent brain tumor
  • multiple brain tumor localizations
  • earlier skull radiotherapy
  • earlier chemotherapy for GBM
  • Chronic Kidney Disease or other renal function disorder
  • known MR-contrast allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire de Liege

Liège, Belgium

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Henk van Santbrink, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Didier Martin, MD, PhD

    Centre Hospitalier Universitaire de Liege

    PRINCIPAL INVESTIGATOR

  • Koo van Overbeeke, MD, PhD

    Maastricht University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 21, 2009

Study Start

February 1, 2010

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

BE(1)NL(1)