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N/A N=58 Randomized Single-blind Treatment

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

Glioma

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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