iMRI Guided Resection in Cerebral Glioma Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Huashan Hospital
Sponsor:
Information provided by (Responsible Party):
Jinsong Wu, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT01479686
First received: November 19, 2011
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Glioma
Procedure: iMRI
Procedure: conventional neuronavigation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Huashan Hospital:

Primary Outcome Measures:
  • Extent of resection [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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 and stratified as: GTR, 100% resection; subtotal resection ≥ 90% resection, partial resection ≥ 70% resection, and biopsy.


Secondary Outcome Measures:
  • OS [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    overal survival

  • PFS [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Postoperative complications: e.g., postoperative epilepsy, infection, bleeding and infarction.

  • Health economics [ Time Frame: after surgery ] [ Designated as safety issue: Yes ]
    Health economics: surgical time, surgical cost, postoperative hospitalization days, and hospitalization expenses

  • MRI-related adverse events [ Time Frame: after surgery ] [ Designated as safety issue: Yes ]
    MRI-related adverse events: risks of airway management, burn, MRI mechanical damage, and other safety analysis.

  • Surgery related morbidity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Assessment of motor and language functions (Morbidity): whether there are newly postoperative hemiplegia or aphasia.


Estimated Enrollment: 303
Study Start Date: September 2011
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional neuronavigation
conventional neuronavigation guided resection in adults with glioma
Procedure: conventional neuronavigation
conventional neuronavigation guided resection in adults with glioma
Experimental: intraoperative MRI
iMRI guided resection in adults with glioma
Procedure: iMRI
3.0TiMRI guided resection in adults with glioma

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479686

Contacts
Contact: Liang-fu Zhou, M.D. +86 21 52887200 lfzhouc@fudan.edu.cn
Contact: Jin-song Wu, M.D.,Ph.D. +86 21 52887200 wjsongc@126.com

Locations
China, Shanghai
Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Liang-fu Zhou, M.D.    +86 21 52887200    lfzhouc@fudan.edu.cn   
Contact: Jin-song Wu, M.D., Ph.D    +86 21 52887200    wjsongc@126.com   
Principal Investigator: Liang-fu Zhou, M.D.         
Principal Investigator: Ying Mao, M.D.,Ph.D.         
Principal Investigator: Jin-song Wu, M.D.,Ph.D.         
Sponsors and Collaborators
Huashan Hospital
Investigators
Study Chair: Liang-fu Zhou, M.D. Huashan Hospital, Fudan University
Principal Investigator: Ying Mao, M.D., Ph.D Huashan Hospital, Fudan University
Principal Investigator: Jin-song Wu, M.D., Ph.D Huashan Hospital, Fudan University
  More Information

No publications provided

Responsible Party: Jinsong Wu, M.D.,Ph.D., Huashan Hospital
ClinicalTrials.gov Identifier: NCT01479686     History of Changes
Other Study ID Numbers: XBR2011022
Study First Received: November 19, 2011
Last Updated: February 24, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Huashan Hospital:
GLIOMA
NEURONAVIGATION
INTERVENTIONAL MRI

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 24, 2014