NCT01394692

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

Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Goethe University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioma

Interventions

Type	Name	Description
PROCEDURE	intraoperative MRI-guided tumor resection	tumor resection with the use of an intraoperative MRI
PROCEDURE	standard microsurgery	microsurgical tumor resection

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-07-01
• Completion: 2011-01-01
• First posted: 2011-07-14
• Last updated: 2012-11-28
• Results posted: 2012-11-28

Locations

1 site across 1 country: Germany