GliomaNCT01394692
Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery
A study testing intraoperative MRI-guided tumor resection and standard microsurgery in people with Glioma, run by Goethe University at 1 site in Germany.
Trial summary
Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- intraoperative MRI-guided tumor resection and standard microsurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- known or suspected contrast-enhancing glioma (primary and recurrent)
- location of the tumor permits intended gross-total resection
Who cannot join
- tumor location prohibits or questions gross-total resection
- contraindications to undergo MRI examinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI
Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition.
In order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. The intraoperative MRI devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow.
Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma surgery are lacking. To assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative MRI-guidance, we designed this prospective, randomized trial. We hypothesized that the extent of resection that can be achieved using an intraoperative MRI is greater than that of conventional microsurgical tumor resection.
- Conditions
- Glioma
- Being tested
- intraoperative MRI-guided tumor resection, standard microsurgery
- Keywords
- intraoperative MRI, glioma surgery, extent of resection
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative MRI-guided tumor resectionProcedure or surgery
Also called PoleStar-N20 intraoperative MRI
tumor resection with the use of an intraoperative MRI
standard microsurgeryProcedure or surgery
microsurgical tumor resection
| Study group | Role | What they receive |
|---|---|---|
| intraoperative MRI | Active comparator | tumor resection with intraoperative MRI-guidance Receives: Procedure: intraoperative MRI-guided tumor resection |
| conventional group | Active comparator | standard microsurgical tumor resection Receives: Procedure: standard microsurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of Resection
Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved
Measured: 72 hours
Secondary outcomes (3)
Progression-free Survival
Progression-free survival (radiological and/or clinical progression) at 6 months following surgery
Measured: 6 months
Volumetric Assessment
Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI
Measured: 72 hours
Neurological Deficit
Assessment of new postoperative deficits following tumor surgery
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startOct 2007
- Primary completionJul 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Senft, Goethe University
- Investigators
- Christian Senft, M.D., Principal investigator, Goethe UniversityVolker Seifert, M.D., Study director, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394692
- Sponsor's protocol ID
- JWG-EK 239/07
- Status last verified
- Oct 2012
- First submitted
- 13 Jul 2011
- Last updated
- 28 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Senft C, Bink A, Franz K, Vatter H, Gasser T, Seifert V. Intraoperative MRI guidance and extent of resection in glioma surgery: a randomised, controlled trial. Lancet Oncol. 2011 Oct;12(11):997-1003. doi: 10.1016/S1470-2045(11)70196-6. Epub 2011 Aug 23.
PubMed 21868284
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI
- ClinicalTrials.gov ID
- NCT01394692
- Acronym / sponsor ID
- JWG-EK 239/07
- Conditions
- Glioma
- Keywords
- intraoperative MRI, glioma surgery, extent of resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Posted 28 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition.
In order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. The intraoperative MRI devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow.
Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma surgery are lacking. To assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative MRI-guidance, we designed this prospective, randomized trial. We hypothesized that the extent of resection that can be achieved using an intraoperative MRI is greater than that of conventional microsurgical tumor resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraoperative MRI | Active comparator | Procedure: intraoperative MRI-guided tumor resectiontumor resection with intraoperative MRI-guidance |
| conventional group | Active comparator | Procedure: standard microsurgerystandard microsurgical tumor resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- known or suspected contrast-enhancing glioma (primary and recurrent)
- location of the tumor permits intended gross-total resection
Key exclusion criteria (2 listed)
- tumor location prohibits or questions gross-total resection
- contraindications to undergo MRI examinations
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 |
|---|---|---|
| intraoperative MRI-guided tumor resectionAlso: PoleStar-N20 intraoperative MRItumor resection with the use of an intraoperative MRI | Procedure or surgery | intraoperative MRI |
| standard microsurgerymicrosurgical tumor resection | Procedure or surgery | conventional group |
Primary outcome
Extent of Resection
Time frame: 72 hours
Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved
3 secondary outcomes
Progression-free Survival
Time frame: 6 months
Volumetric Assessment
Time frame: 72 hours
Neurological Deficit
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21868284Senft C, Bink A, Franz K, Vatter H, Gasser T, Seifert V. Intraoperative MRI guidance and extent of resection in glioma surgery: a randomised, controlled trial. Lancet Oncol. 2011 Oct;12(11):997-1003. doi: 10.1016/S1470-2045(11)70196-6. Epub 2011 Aug 23.
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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.
Christian Senft, M.D. principal investigator
Goethe University
Volker Seifert, M.D. study director
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative MRI-guided tumor resection and standard microsurgery in people with Glioma, run by Goethe University at 1 site in Germany.
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 2 inclusion and 2 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 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Yes. Results are posted in the registry (first posted 28 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extent of Resection (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01394692, which also lists 1 linked publication.
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 28 Nov 2012.