Status:
COMPLETED
iMRI Guided Resection in Cerebral Glioma Surgery
Lead Sponsor:
Huashan Hospital
Conditions:
Glioma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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, leve...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT01479686
Start Date
September 1 2011
End Date
March 1 2021
Last Update
October 19 2021
Active Locations (1)
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1
Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University
Shanghai, Shanghai Municipality, China, 200040