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

Not Applicable

Completed

• Conditions: Glioma
• Interventions: Procedure: standard microsurgery; Procedure: intraoperative MRI-guided tumor resection

• Registration Number: NCT01394692
• Lead Sponsor: Goethe University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2010-07
• Study Completion: 2011-01
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Results First Submitted: 2012-09-20
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-29
• Last Update Submitted: 2012-10-29
• Results First Posted: 2012-11-28
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional group	standard microsurgery	standard microsurgical tumor resection
intraoperative MRI	intraoperative MRI-guided tumor resection	tumor resection with intraoperative MRI-guidance

Primary Outcome Measures

Name	Time	Method
Extent of Resection	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

Name	Time	Method
Progression-free Survival	6 months	Progression-free survival (radiological and/or clinical progression) at 6 months following surgery
Volumetric Assessment	72 hours	Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI
Neurological Deficit	7 days	Assessment of new postoperative deficits following tumor surgery

Trial Locations

Locations (1)

Department of Neurosurgery, Goethe-University; 🇩🇪 Frankfurt, Germany