NCT01479686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

7 years

First QC Date

November 19, 2011

Last Update Submit

October 16, 2021

Conditions

Glioma

Keywords

GLIOMANEURONAVIGATIONINTERVENTIONAL MRI

Outcome Measures

Primary Outcomes (1)

  • 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).

    3 years

Secondary Outcomes (6)

  • OS

    10 years

  • PFS

    10 years

  • Postoperative complications

    after surgery

  • Health economics

    after surgery

  • MRI-related adverse events

    after surgery

  • +1 more secondary outcomes

Study Arms (2)

conventional neuronavigation

ACTIVE COMPARATOR

conventional neuronavigation guided resection in adults with glioma

Procedure: conventional neuronavigation

intraoperative MRI

EXPERIMENTAL

iMRI guided resection in adults with glioma

Procedure: iMRI

Interventions

iMRIPROCEDURE

3.0TiMRI guided resection in adults with glioma

intraoperative MRI
conventional neuronavigationPROCEDURE

conventional neuronavigation guided resection in adults with glioma

conventional neuronavigation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • +4 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (1)

  • 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.

    PMID: 33428222DERIVED

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Liang-fu Zhou, M.D.

    Huashan Hospital

    STUDY CHAIR

  • Ying Mao, M.D., Ph.D

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

  • Jin-song Wu, M.D., Ph.D

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.,Ph.D.

Study Record Dates

First Submitted

November 19, 2011

First Posted

November 24, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2018

Study Completion

March 1, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

CN(1)