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iMRI Guided Resection in Cerebral Glioma Surgery

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ClinicalTrials.gov Identifier: NCT01479686
Recruitment Status : Active, not recruiting
First Posted : November 24, 2011
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Jinsong Wu, Huashan Hospital

Tracking Information
First Submitted Date  ICMJE November 19, 2011
First Posted Date  ICMJE November 24, 2011
Last Update Posted Date February 22, 2019
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
Extent of resection [ 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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
  • Extent of resection [ Time Frame: 2 years ]
    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)
  • PFS-6 [ Time Frame: 2 years ]
    6-month progression-free survival (PFS-6)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
  • OS [ Time Frame: 10 years ]
    Overall survival analyses for all gliomas and gliomas grouped according to eloquent areas and non-eloquent areas.
  • PFS [ 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.
  • Postoperative complications [ Time Frame: after surgery ]
    Postoperative complications: e.g., postoperative epilepsy, infection, bleeding and infarction.
  • Health economics [ Time Frame: after surgery ]
    Health economics: surgical time, surgical cost, postoperative hospitalization days, and hospitalization expenses
  • MRI-related adverse events [ Time Frame: after surgery ]
    MRI-related adverse events: risks of airway management, burn, MRI mechanical damage, and other safety analysis.
  • Surgery related morbidity [ Time Frame: 3 years ]
    Assessment of motor and language functions (Morbidity): whether there are newly postoperative hemiplegia or aphasia.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
  • OS [ Time Frame: 10 years ]
    overal survival
  • PFS [ Time Frame: 10 years ]
    progression free survival time
  • Postoperative complications [ Time Frame: 10 years ]
    Postoperative complications: e.g., postoperative epilepsy, infection, bleeding and infarction.
  • Health economics [ Time Frame: 10 years ]
    Health economics: surgical time, surgical cost, postoperative hospitalization days, and hospitalization expenses
  • MRI-related adverse events [ Time Frame: 10 years ]
    MRI-related adverse events: risks of airway management, burn, MRI mechanical damage, and other safety analysis.
  • Morbidity [ Time Frame: 10 years ]
    Assessment of motor and language functions (Morbidity): whether there are newly postoperative hemiplegia or aphasia.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE iMRI Guided Resection in Cerebral Glioma Surgery
Official Title  ICMJE 3.0T High-field Intraoperative MRI Guided Extent of Resection in Cerebral Glioma Surgery: a Single Center Prospective Randomized Triple-blind Controlled Clinical Trial
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Glioma
Intervention  ICMJE
  • Procedure: iMRI
    3.0TiMRI guided resection in adults with glioma
  • Procedure: conventional neuronavigation
    conventional neuronavigation guided resection in adults with glioma
Study Arms  ICMJE
  • Active Comparator: conventional neuronavigation
    conventional neuronavigation guided resection in adults with glioma
    Intervention: Procedure: conventional neuronavigation
  • Experimental: intraoperative MRI
    iMRI guided resection in adults with glioma
    Intervention: Procedure: iMRI
Publications * Fountain DM, Bryant A, Barone DG, Waqar M, Hart MG, Bulbeck H, Kernohan A, Watts C, Jenkinson MD. Intraoperative imaging technology to maximise extent of resection for glioma: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jan 4;1:CD013630. doi: 10.1002/14651858.CD013630.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 20, 2019)
321
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2011)
316
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Individuals aged 18-70 years with highly suspected (as assessed by study surgeon), newly diagnosed, untreated malignant glioma (see appendix 1)
  2. Individuals with supratentorial gliomas with bodies involving in frontal lobe, temporal lobe, parietal lobe, occipital lobe or insular lobe
  3. Individuals with the preoperative assessment that radiological radicality should be achieved
  4. Individuals either with or without tumor in eloquent areas (see appendix 2)
  5. Karnofsky performance scale 70 or more
  6. All patients gave written informed consent.

Appendix 1. Histological types(WHO 2007):

  1. Astrocytic tumours:Pilomyxoid astrocytoma 9425/3 Pleomorphic xanthoastrocytoma 9424/3 Diffuse astrocytoma 9400/3 Fibrillary astrocytoma 9420/3 Gemistocytic astrocytoma 9411/3 Protoplasmic astrocytoma 9410/3 Anaplastic astrocytoma 9401/3 Glioblastoma 9440/3 Giant cell glioblastoma 9441/3 Gliosarcoma 9442/3
  2. Oligodendroglial tumours:Oligodendroglioma 9450/3 Anaplastic oligodendroglioma 9451/3
  3. Oligoastrocytic tumours:Oligoastrocytoma 9382/3 Anaplastic oligoastrocytoma 9382/3
  4. Ependymal tumours:Ependymoma 9391/3 Cellular 9391/3 Papillary 9393/3 Clear cell 9391/3 Tanycytic 9391/3 Anaplastic ependymoma 9392/3

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:

  1. Frontal lobe, which divided into inferior frontal gyrus (BA44-Pars opercularis, BA45-Pars triangularis/Broca's area), middle frontal gyrus (BA9, BA46), superior frontal gyrus (BA4, BA6, BA8), primary motor cortex (BA4), premotor cortex (BA6), and supplementary motor area (BA6)
  2. Parietal lobe, which divided into inferior parietal lobule (BA40-supramarginal gyrus, BA39-angular gyrus), parietal operculum (BA43), and primary somatosensory cortex (BA1, BA2, BA3)
  3. Temporal lobe, which divided into transverse temporal gyrus (BA41, BA42), superior temporal gyrus (BA38, BA22/Wernicke's area), middle temporal gyrus (BA21)
  4. Insular lobe.

Exclusion Criteria:

  1. Individuals with age < 18 years or > 70 years
  2. Tumours of the midline, basal ganglia, cerebellum, or brain stem
  3. Recurrent gliomas after surgery (except needle biopsy)
  4. Primary gliomas with history of radiotherapy or chemotherapy
  5. Contraindications precluding intraoperative MRI-guided surgery
  6. Inability to give informed consent
  7. KPS < 70
  8. Renal insufficiency or hepatic insufficiency
  9. History of malignant tumours at any body site
  10. Tumour locations (in important eloquent area) do not enable complete resection of tumour.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01479686
Other Study ID Numbers  ICMJE XBR2011022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jinsong Wu, Huashan Hospital
Study Sponsor  ICMJE Huashan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Liang-fu Zhou, M.D. Huashan Hospital
Principal Investigator: Ying Mao, M.D., Ph.D Huashan Hospital
Principal Investigator: Jin-song Wu, M.D., Ph.D Huashan Hospital
PRS Account Huashan Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP