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

Primary Purpose

Glioma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
intraoperative MRI-guided tumor resection
standard microsurgery
Sponsored by
Goethe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring intraoperative MRI, glioma surgery, extent of resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurosurgery, Goethe-University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

intraoperative MRI

conventional group

Arm Description

tumor resection with intraoperative MRI-guidance

standard microsurgical tumor resection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression-free Survival
Progression-free survival (radiological and/or clinical progression) at 6 months following surgery
Volumetric Assessment
Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI
Neurological Deficit
Assessment of new postoperative deficits following tumor surgery

Full Information

First Posted
July 13, 2011
Last Updated
October 29, 2012
Sponsor
Goethe University
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1. Study Identification

Unique Protocol Identification Number
NCT01394692
Brief Title
Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery
Official Title
Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
intraoperative MRI, glioma surgery, extent of resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intraoperative MRI
Arm Type
Active Comparator
Arm Description
tumor resection with intraoperative MRI-guidance
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
standard microsurgical tumor resection
Intervention Type
Procedure
Intervention Name(s)
intraoperative MRI-guided tumor resection
Other Intervention Name(s)
PoleStar-N20 intraoperative MRI
Intervention Description
tumor resection with the use of an intraoperative MRI
Intervention Type
Procedure
Intervention Name(s)
standard microsurgery
Intervention Description
microsurgical tumor resection
Primary Outcome Measure Information:
Title
Extent of Resection
Description
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
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival (radiological and/or clinical progression) at 6 months following surgery
Time Frame
6 months
Title
Volumetric Assessment
Description
Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI
Time Frame
72 hours
Title
Neurological Deficit
Description
Assessment of new postoperative deficits following tumor surgery
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Senft, M.D.
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Volker Seifert, M.D.
Organizational Affiliation
Goethe University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neurosurgery, Goethe-University
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21868284
Citation
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.
Results Reference
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Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery

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