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Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery

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ClinicalTrials.gov Identifier: NCT01394692
Recruitment Status : Completed
First Posted : July 14, 2011
Results First Posted : November 28, 2012
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Christian Senft, Goethe University

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Glioma Procedure: intraoperative MRI-guided tumor resection Procedure: standard microsurgery Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI
Study Start Date : October 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : January 2011

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: intraoperative MRI
tumor resection with intraoperative MRI-guidance
 Procedure: intraoperative MRI-guided tumor resection
tumor resection with the use of an intraoperative MRI
Other Name: PoleStar-N20 intraoperative MRI
Active Comparator: conventional group
standard microsurgical tumor resection
 Procedure: standard microsurgery
microsurgical tumor resection


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 6 months ]
    Progression-free survival (radiological and/or clinical progression) at 6 months following surgery

  2. Volumetric Assessment [ Time Frame: 72 hours ]
    Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI

  3. Neurological Deficit [ Time Frame: 7 days ]
    Assessment of new postoperative deficits following tumor surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • known or suspected contrast-enhancing glioma (primary and recurrent)
  • location of the tumor permits intended gross-total resection

Exclusion Criteria:

  • tumor location prohibits or questions gross-total resection
  • contraindications to undergo MRI examinations
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394692


Locations
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Germany
Department of Neurosurgery, Goethe-University
Frankfurt, Germany, 60528
Sponsors and Collaborators
Goethe University
Investigators
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Principal Investigator: Christian Senft, M.D. Goethe University
Study Director: Volker Seifert, M.D. Goethe University
More Information
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Publications of Results:

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Responsible Party: Christian Senft, Neurosurgeon, Goethe University
ClinicalTrials.gov Identifier: NCT01394692    
Other Study ID Numbers: JWG-EK 239/07
First Posted: July 14, 2011    Key Record Dates
Results First Posted: November 28, 2012
Last Update Posted: November 28, 2012
Last Verified: October 2012
Keywords provided by Christian Senft, Goethe University:
intraoperative MRI
glioma surgery
extent of resection
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue