iMRI Guided Resection in Cerebral Glioma Surgery
Condition: Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 3

Summary: 
      Many clinical studies have been reported on iMRI, however, their evidence levels are
      relatively not as good as what people hope they will be. Based on the available literature,
      there is, at best, level 2 evidence that iMRI-guided surgery is more effective than
      conventional neuronavigation-guided surgery.

      The investigators aim to do a single center prospective randomized triple-blind controlled
      clinical trial to assess the effect of 3.0T high-field intraoperative MRI-guided glioma
      resection on surgical efficiency and progression-free survival of malignant glioma to provide
      a level 2A evidence for its clinical application.
    

Detailed description: 
      Since the first introduction of the GE Signa System by the Brigham and Women's Hospital as
      the world's first intraoperative MRI in 1993, iMRI has been so increasingly applied that it
      has been one of the most important techniques and concepts in the field of neurosurgery. Many
      clinical studies have been reported on this respect, however, their evidence levels are
      relatively not as good as what people hope they will be.Based on the available literature,
      there is, at best, level 2B evidence that iMRI-guided surgery is more effective than
      conventional neuronavigation-guided surgery.

      Rationale: Intraoperative magnetic resonance imaging (MRI)-guided intracranial surgery, one
      of whose most frequently reported indications is cerebral glioma surgery, may help update
      images for navigational systems, providing data on the extent of resection and localization
      of tumor remnants, and thereby enable intraoperative reliable immediate resection control to
      eliminate the effect of brain shift on the extent of resection. Intraoperative MRI systems
      can be divided into low-field intraoperative MRI(0.5T or less) and high-field intraoperative
      MRI (1.5T or more) according to their various field strengths. The latter enables
      intraoperative imaging at higher quality and more available imaging modalities but with more
      cost and equipment requirements.

      Purpose: We aim to do a single center prospective randomized triple-blind controlled clinical
      trial to assess the effect of 3.0T high-field intraoperative MRI-guided glioma resection on
      surgical efficiency and progression-free survival of malignant glioma. We hypothesize that
      the use of high-field intraoperative MRI will enable more complete tumor resection than
      conventional neuronavigation-guided resection,reducing the morbidity and leading to more
      improved progression-free survival and quality of life in patients with malignant glioma.
    

Intervention name(s): iMRI; conventional neuronavigation
Intervention type(s): Procedure; Procedure
Intervention description(s): 3.0TiMRI guided resection in adults with glioma; conventional neuronavigation guided resection in adults with glioma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GLIOMA; NEURONAVIGATION; INTERVENTIONAL MRI