N/A
N=58
Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery
Glioma
Bottom Line
View on ClinicalTrials.gov: NCT01394692 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Extent of Resection — 24; 25 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- intraoperative MRI-guided tumor resection (Procedure); standard microsurgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Goethe University
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extent of Resection |
24; 25 | — |
| SECONDARY Progression-free Survival |
— | — |
| SECONDARY Volumetric Assessment |
— | — |
| SECONDARY Neurological Deficit |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01394692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.