3.0T High-field Intraoperative MRI Guided Extent of Resection in Cerebral Glioma Surgery: a Single Center Prospective Randomized Triple-blind Controlled Clinical Trial
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Extent of resection
Extent of resection (EOR) based on early postoperative MRI obtained within 72 h after surgery, including volumetric MRI analysis(GTR-100%, STR-90%, PR-70%, Biopsy)
Liang-fu Zhou, M.D.
Huashan Hospital, Fudan University
China: Food and Drug Administration