Glioblastoma MultiformeRACINGNCT00943007
Comparison of Standard Neuronavigation With Intraoperative Magnetic Resonance Imaging (MRI) for the Neurosurgical Treatment of Malignant Brain Tumors
A study testing Stealth Station and PoleStar N20 in people with Glioblastoma Multiforme, run by Maastricht University Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Stealth Station and PoleStar N20
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas
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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Stealth Station, PoleStar N20
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stealth StationDevice
Also called cNN
Neuronavigation based on preoperative MRI
PoleStar N20Device
Also called iMRI
Intraoperative MRI guided surgery
| Study group | Role | What they receive |
|---|---|---|
| Conventional Neuronavigation | Active comparator | Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift Receives: Device: Stealth Station |
| Intraoperative MRI | Experimental | Standard neuronavigation plus intraoperative MRI to correct for brain shift Receives: Device: PoleStar N20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Residual tumor volume
Measured: <72h after surgery
Secondary outcomes (2)
Complications, Clinical Performance, and Quality of Life
Measured: 3 months after surgery
Survival
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startFeb 2010
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henk van Santbrink, MD, PhD, Principal investigator, Maastricht University Medical CenterDidier Martin, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de LiegeKoo van Overbeeke, MD, PhD, Study chair, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943007
- Sponsor's protocol ID
- MEC 08-2-055
- Acronym
- RACING
- Status last verified
- Apr 2015
- First submitted
- 20 Jul 2009
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas
- ClinicalTrials.gov ID
- NCT00943007
- Acronym / sponsor ID
- RACING / MEC 08-2-055
- Conditions
- Glioblastoma Multiforme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Neuronavigation | Active comparator | Device: Stealth StationStandard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift |
| Intraoperative MRI | Experimental | Device: PoleStar N20Standard neuronavigation plus intraoperative MRI to correct for brain shift |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- recurrent brain tumor
- multiple brain tumor localizations
- earlier skull radiotherapy
- earlier chemotherapy for GBM
- Chronic Kidney Disease or other renal function disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stealth StationAlso: cNNNeuronavigation based on preoperative MRI | Device | Conventional Neuronavigation |
| PoleStar N20Also: iMRIIntraoperative MRI guided surgery | Device | Intraoperative MRI |
Primary outcome
Difference in Residual tumor volume
Time frame: <72h after surgery
2 secondary outcomes
Complications, Clinical Performance, and Quality of Life
Time frame: 3 months after surgery
Survival
Time frame: 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk van Santbrink, MD, PhD principal investigator
Maastricht University Medical Center
Didier Martin, MD, PhD principal investigator
Centre Hospitalier Universitaire de Liege
Koo van Overbeeke, MD, PhD study chair
Maastricht University Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stealth Station and PoleStar N20 in people with Glioblastoma Multiforme, run by Maastricht University Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Residual tumor volume (time frame: <72h after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.