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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Senft, Goethe University
ClinicalTrials.gov Identifier:
NCT01394692
First received: July 13, 2011
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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 Intervention
Glioma
Procedure: intraoperative MRI-guided tumor resection
Procedure: standard microsurgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI

Resource links provided by NLM:


Further study details as provided by Goethe University:

Primary Outcome Measures:
  • Extent of Resection [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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:
  • Progression-free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Progression-free survival (radiological and/or clinical progression) at 6 months following surgery

  • Volumetric Assessment [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI

  • Neurological Deficit [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Assessment of new postoperative deficits following tumor surgery


Enrollment: 58
Study Start Date: October 2007
Study Completion Date: January 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01394692

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

Publications:
Responsible Party: Christian Senft, Neurosurgeon, Goethe University
ClinicalTrials.gov Identifier: NCT01394692     History of Changes
Other Study ID Numbers: JWG-EK 239/07
Study First Received: July 13, 2011
Results First Received: September 20, 2012
Last Updated: October 29, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Goethe University:
intraoperative MRI
glioma surgery
extent of resection

Additional relevant MeSH terms:
Glioma
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014