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iMRI Guided Resection in Cerebral Glioma Surgery

Primary Purpose

Glioma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
iMRI
conventional neuronavigation
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring GLIOMA, NEURONAVIGATION, INTERVENTIONAL MRI

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional neuronavigation

intraoperative MRI

Arm Description

conventional neuronavigation guided resection in adults with glioma

iMRI guided resection in adults with glioma

Outcomes

Primary Outcome Measures

Extent of resection
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).

Secondary Outcome Measures

OS
Overall survival analyses for all gliomas and gliomas grouped according to eloquent areas and non-eloquent areas.
PFS
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
Postoperative complications: e.g., postoperative epilepsy, infection, bleeding and infarction.
Health economics
Health economics: surgical time, surgical cost, postoperative hospitalization days, and hospitalization expenses
MRI-related adverse events
MRI-related adverse events: risks of airway management, burn, MRI mechanical damage, and other safety analysis.
Surgery related morbidity
Assessment of motor and language functions (Morbidity): whether there are newly postoperative hemiplegia or aphasia.

Full Information

First Posted
November 19, 2011
Last Updated
October 16, 2021
Sponsor
Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01479686
Brief Title
iMRI Guided Resection in Cerebral Glioma Surgery
Official Title
3.0T High-field Intraoperative MRI Guided Extent of Resection in Cerebral Glioma Surgery: a Single Center Prospective Randomized Triple-blind Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
GLIOMA, NEURONAVIGATION, INTERVENTIONAL MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional neuronavigation
Arm Type
Active Comparator
Arm Description
conventional neuronavigation guided resection in adults with glioma
Arm Title
intraoperative MRI
Arm Type
Experimental
Arm Description
iMRI guided resection in adults with glioma
Intervention Type
Procedure
Intervention Name(s)
iMRI
Intervention Description
3.0TiMRI guided resection in adults with glioma
Intervention Type
Procedure
Intervention Name(s)
conventional neuronavigation
Intervention Description
conventional neuronavigation guided resection in adults with glioma
Primary Outcome Measure Information:
Title
Extent of resection
Description
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
3 years
Secondary Outcome Measure Information:
Title
OS
Description
Overall survival analyses for all gliomas and gliomas grouped according to eloquent areas and non-eloquent areas.
Time Frame
10 years
Title
PFS
Description
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
10 years
Title
Postoperative complications
Description
Postoperative complications: e.g., postoperative epilepsy, infection, bleeding and infarction.
Time Frame
after surgery
Title
Health economics
Description
Health economics: surgical time, surgical cost, postoperative hospitalization days, and hospitalization expenses
Time Frame
after surgery
Title
MRI-related adverse events
Description
MRI-related adverse events: risks of airway management, burn, MRI mechanical damage, and other safety analysis.
Time Frame
after surgery
Title
Surgery related morbidity
Description
Assessment of motor and language functions (Morbidity): whether there are newly postoperative hemiplegia or aphasia.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals aged 18-70 years with highly suspected (as assessed by study surgeon), newly diagnosed, untreated malignant glioma (see appendix 1) Individuals with supratentorial gliomas with bodies involving in frontal lobe, temporal lobe, parietal lobe, occipital lobe or insular lobe Individuals with the preoperative assessment that radiological radicality should be achieved Individuals either with or without tumor in eloquent areas (see appendix 2) Karnofsky performance scale 70 or more All patients gave written informed consent. Appendix 1. Histological types（WHO 2007）: 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 Oligodendroglial tumours:Oligodendroglioma 9450/3 Anaplastic oligodendroglioma 9451/3 Oligoastrocytic tumours:Oligoastrocytoma 9382/3 Anaplastic oligoastrocytoma 9382/3 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: 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) Parietal lobe, which divided into inferior parietal lobule (BA40-supramarginal gyrus, BA39-angular gyrus), parietal operculum (BA43), and primary somatosensory cortex (BA1, BA2, BA3) Temporal lobe, which divided into transverse temporal gyrus (BA41, BA42), superior temporal gyrus (BA38, BA22/Wernicke's area), middle temporal gyrus (BA21) Insular lobe. Exclusion Criteria: Individuals with age < 18 years or > 70 years Tumours of the midline, basal ganglia, cerebellum, or brain stem Recurrent gliomas after surgery (except needle biopsy) Primary gliomas with history of radiotherapy or chemotherapy Contraindications precluding intraoperative MRI-guided surgery Inability to give informed consent KPS < 70 Renal insufficiency or hepatic insufficiency History of malignant tumours at any body site Tumour locations (in important eloquent area) do not enable complete resection of tumour.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang-fu Zhou, M.D.
Organizational Affiliation
Huashan Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ying Mao, M.D., Ph.D
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin-song Wu, M.D., Ph.D
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33428222
Citation
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(1):CD013630. doi: 10.1002/14651858.CD013630.pub2.
Results Reference
derived

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iMRI Guided Resection in Cerebral Glioma Surgery

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