Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University
Shanghai, Shanghai Municipality, 200040, China
NCT Number: NCT01479686
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 3
Shanghai, Shanghai Municipality, 200040, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Appendix 1. Histological types(WHO 2007):
Morphology code of the International Classification of Diseases for Oncology (ICD-O) {614A} and the Systematized Nomenclature of Medicine (http://snomen.org). Behaviour is coded /0 for benign tumours, /3 for malignant tumours and /1 for borderline or uncertain behaviour.
Tumor grade: grade II~IV according to the latest WHO grading criteria;
Appendix 2. Tumor location in eloquent areas:
located in or close to areas of the dominant-hemisphere that associated with motor or language functions, including:
Exclusion criteria
3.0TiMRI guided resection in adults with glioma
conventional neuronavigation guided resection in adults with glioma
Time frame: 3 years
Extent of resection (EOR) based on early postoperative MRI obtained within 72 h after surgery. Gross total resection (GTR) was defined as the complete disappearance of all enhancing lesions (T1WI) for HGG and the complete disappearance of all nonenhancing (T2WI FLAIR) lesions for LGG. The EOR were quantitatively volumetric analyses for all gliomas and gliomas grouped according to eloquent areas and non-eloquent areas, and stratified as: GTR, 100% resection; subtotal resection ≥ 90% resection, partial resection ≥ 70% resection, biopsy, resection ≥98% for OS advantage (HGG) and resection ≥90% for OS advantage (LGG).
Time frame: 10 years
Overall survival analyses for all gliomas and gliomas grouped according to eloquent areas and non-eloquent areas.
Time frame: 10 years
Neuropathological confirmed non-glioma lesions or benign histologies are excluded from the secondary endpoints follow up. All participants were observed, with serial clinical evaluations and MRI scans every 3 months following interventions, which was the routine for these diseases. Progression was defined in accordance with RANO criteria.
Time frame: after surgery
Postoperative complications: e.g., postoperative epilepsy, infection, bleeding and infarction.
Time frame: after surgery
Health economics: surgical time, surgical cost, postoperative hospitalization days, and hospitalization expenses
Time frame: after surgery
MRI-related adverse events: risks of airway management, burn, MRI mechanical damage, and other safety analysis.
Time frame: 3 years
Assessment of motor and language functions (Morbidity): whether there are newly postoperative hemiplegia or aphasia.
Huashan Hospital
Other
3.0T High-field Intraoperative MRI Guided Extent of Resection in Cerebral Glioma Surgery: a Single Center Prospective Randomized Triple-blind Controlled Clinical Trial
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