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

NCT ID: NCT01394692

Last Updated: 2012-11-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glioma

Keywords

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intraoperative MRI glioma surgery extent of resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intraoperative MRI

tumor resection with intraoperative MRI-guidance

Group Type ACTIVE_COMPARATOR

intraoperative MRI-guided tumor resection

Intervention Type PROCEDURE

tumor resection with the use of an intraoperative MRI

conventional group

standard microsurgical tumor resection

Group Type ACTIVE_COMPARATOR

standard microsurgery

Intervention Type PROCEDURE

microsurgical tumor resection

Interventions

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intraoperative MRI-guided tumor resection

tumor resection with the use of an intraoperative MRI

Intervention Type PROCEDURE

standard microsurgery

microsurgical tumor resection

Intervention Type PROCEDURE

Other Intervention Names

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PoleStar-N20 intraoperative MRI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goethe University

OTHER

Sponsor Role lead

Responsible Party

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Christian Senft

Neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Senft, M.D.

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Volker Seifert, M.D.

Role: STUDY_DIRECTOR

Goethe University

Locations

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Department of Neurosurgery, Goethe-University

Frankfurt, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 21868284 (View on PubMed)

Other Identifiers

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JWG-EK 239/07

Identifier Type: -

Identifier Source: org_study_id