- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Diagnostic Accuracy of Susceptibility-Weighted Imaging (SWI)
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Neoplasmer, körtel och epitel
- Neoplasmer, neuroepitelial
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Neoplasmer i nervsystemet
- Neoplasmer i centrala nervsystemet
- Gliom
- Neoplasmer i hjärnan
Andra studie-ID-nummer
- SWI in Cerebral Glioma Grading
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