CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
intraoperative MRI-guided tumor resection +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01394692
NCT01394692N/ACompleted

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

Goethe University·interventional·Posted Jul 14, 2011·Updated Nov 28, 2012

In Brief

A clinical study evaluating intraoperative MRI-guided tumor resection and standard microsurgery for Glioma. Completed, enrolled 58 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioma
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 14, 2011
Enrollment StartOct 1, 2007
Primary CompletionJul 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.0 years ago

Interventions

intraoperative MRI-guided tumor resectionprocedure

tumor resection with the use of an intraoperative MRI

standard microsurgeryprocedure

microsurgical tumor resection