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AzTrials

GliomaPhase 3NCT01479686

iMRI Guided Resection in Cerebral Glioma Surgery

A Phase 3 study testing iMRI and conventional neuronavigation in people with Glioma, run by Huashan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Glioma
What is being tested?
iMRI and conventional neuronavigation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
1 siteChina
Study dates
Sep 2011to Mar 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Glioma
Being tested
iMRI, conventional neuronavigation
Keywords
GLIOMA, NEURONAVIGATION, INTERVENTIONAL MRI
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iMRIProcedure or surgery

    3.0TiMRI guided resection in adults with glioma

  • conventional neuronavigationProcedure or surgery

    conventional neuronavigation guided resection in adults with glioma

Study groups in NCT01479686
Study groupRoleWhat they receive
conventional neuronavigationActive comparatorconventional neuronavigation guided resection in adults with glioma
Receives: Procedure: conventional neuronavigation
intraoperative MRIExperimentaliMRI guided resection in adults with glioma
Receives: Procedure: iMRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 years

Secondary outcomes (6)

  1. OS

    Overall survival analyses for all gliomas and gliomas grouped according to eloquent areas and non-eloquent areas.

    Measured: 10 years

  2. 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.

    Measured: 10 years

  3. Postoperative complications

    Postoperative complications: e.g., postoperative epilepsy, infection, bleeding and infarction.

    Measured: after surgery

  4. Health economics

    Health economics: surgical time, surgical cost, postoperative hospitalization days, and hospitalization expenses

    Measured: after surgery

  5. MRI-related adverse events

    MRI-related adverse events: risks of airway management, burn, MRI mechanical damage, and other safety analysis.

    Measured: after surgery

  6. Surgery related morbidity

    Assessment of motor and language functions (Morbidity): whether there are newly postoperative hemiplegia or aphasia.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2018
  4. Study completionMar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01479686
Sponsor's protocol ID
XBR2011022
Status last verified
Oct 2021
First submitted
19 Nov 2011
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
Yes

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(1):CD013630. doi: 10.1002/14651858.CD013630.pub2.

    PubMed 33428222

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing iMRI and conventional neuronavigation in people with Glioma, run by Huashan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extent of resection (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01479686, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.

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