- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07813741
Susceptibility-Weighted Imaging in Preoperative Grading of Cerebral Gliomas
Diagnostic Value of Susceptibility-Weighted Imaging (SWI) in Preoperative Grading of Cerebral Gliomas
Gliomas are the most common primary brain tumors in adults. Determining whether a glioma is low-grade or high-grade before surgery is essential for surgical planning, choosing treatment pathways, and determining prognosis. Currently, definitive grading requires invasive tissue sampling through surgical resection or biopsy. Although conventional magnetic resonance imaging (MRI) is routinely performed, conventional sequences often show overlapping features between low-grade and high-grade tumors, limiting their ability to reliably predict tumor grade.
Susceptibility-weighted imaging (SWI) is an advanced MRI sequence sensitive to microscopic magnetic field distortions caused by blood products, calcification, and abnormal tumor blood vessels. On SWI, these features appear as intratumoral susceptibility signals (ITSS). Because high-grade gliomas typically display greater vascular proliferation and microhemorrhages than low-grade gliomas, quantifying ITSS may provide a non-invasive surrogate for tumor grade.
The primary purpose of this prospective observational study is to assess the diagnostic accuracy of SWI in the preoperative grading of cerebral gliomas, comparing imaging findings directly against histopathological examination according to the 2021 World Health Organization (WHO) Classification of Tumors of the Central Nervous System.
Adult participants with radiologically suspected cerebral gliomas who are scheduled for surgical resection or stereotactic biopsy will undergo a standardized preoperative brain MRI protocol. This protocol incorporates SWI alongside conventional MRI sequences, diffusion-weighted imaging (DWI/ADC), and magnetic resonance spectroscopy (MRS). Two independent radiologists blinded to pathology will assess and grade intratumoral susceptibility signals. Following surgery, imaging-predicted grades will be compared with the final tissue pathology to determine the sensitivity, specificity, and overall diagnostic accuracy of SWI.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients aged 18 years and older.
- Neuroimaging (CT or MRI) findings suggestive of cerebral glioma.
- Patients scheduled for surgical resection or stereotactic biopsy.
Exclusion Criteria:
- Previous brain surgery for the same lesion.
- Previous cranial radiotherapy or chemotherapy.
- General contraindications to MRI (e.g., cardiac pacemakers, ferromagnetic implants, or severe claustrophobia).
- Poor-quality MRI examinations compromised by significant motion or susceptibility artifacts.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Suspected Cerebral Glioma Cohort
Adult patients (≥18 years) presenting with radiologically suspected cerebral gliomas who are scheduled for surgical resection or stereotactic biopsy.
All participants undergo a standardized preoperative brain MRI protocol incorporating conventional sequences (T1, T2, FLAIR, pre- and post-contrast T1), diffusion-weighted imaging (DWI/ADC), magnetic resonance spectroscopy (MRS), and 3D susceptibility-weighted imaging (SWI).
Intratumoral susceptibility signals (ITSS) on SWI are graded semi-quantitatively (grades 0 to 3) to differentiate low-grade (grades 0-1) from high-grade (grades 2-3) tumors.
Final tumor grading is established via histopathological examination of the surgical resection or stereotactic biopsy specimen according to the 2021 WHO Classification of Tumors of the Central Nervous System.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diagnostic Accuracy of Susceptibility-Weighted Imaging (SWI)
Time Frame: Baseline
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Diagnostic accuracy is evaluated as the percentage of participants correctly categorized as having low-grade or high-grade cerebral gliomas using preoperative susceptibility-weighted imaging (SWI) intratumoral susceptibility signal (ITSS) grading, compared against the reference standard of histopathological examination according to the 2021 WHO Classification of Tumors of the Central Nervous System.
ITSS is evaluated on a 4-point scale: Grade 0 (no ITSS), Grade 1 (1-5 dot-like/linear signals), Grade 2 (6-10 signals), and Grade 3 (>10 signals or confluent areas).
Scores are dichotomized into low-grade (Grades 0-1) and high-grade (Grades 2-3) gliomas.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Glioma
- Brain Neoplasms
Other Study ID Numbers
- SWI in Cerebral Glioma Grading
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