Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01479686 : iMRI Guided Resection in Cerebral Glioma Surgery
PhasePhase 3
AgesMin: 18 Years Max: 70 Years
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01479686      |      Link to official Clinicaltrials.gov listing
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