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This study is a prospective, single-center, observational clinical trial, enrolling 100 patients with malignant bladder tumors admitted to the Department of Urology at the People's Hospital of Jiangsu Province for treatment with transurethral resection or radical cystectomy.
All enrolled patients underwent multiparametric magnetic resonance imaging, including T2-weighted imaging (T2WI) in coronal, sagittal, and axial planes and diffusion-weighted imaging (DWI) in the same planes. The Vascular Invasion- and Invasion into the Detrusor muscle Assessment and Reporting System (VI-RADS) scores were evaluated for the enrolled patients. Diagnostic thresholds for muscle-invasive bladder cancer (MIBC) were set at VI-RADS scores ≥3 and ≥4, respectively. Descriptive statistics including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated and compared against the surgical pathology gold standard results.
This study preliminarily validates the diagnostic performance of the 3D magnetic resonance-derived VI-RADS score in the assessment of muscle-invasive bladder cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Radiation | All enrolled patients underwent multiparametric magnetic resonance imaging, encompassing T2-weighted imaging (T2WI) and magnetic resonance diffusion-weighted imaging (DWI), in the coronal, sagittal, and axial planes. |
| Measure | Description | Time Frame |
|---|---|---|
| VI-RADS score | All enrolled patients underwent multiparametric MRI, which included T2WI (coronal, sagittal, axial planes) and diffusion-weighted imaging (DWI) in the coronal, sagittal, and axial planes to evaluate the VI-RADS score. A VI-RADS score of ≥3 and ≥4 were used as cutoff values for the diagnosis of MIBC. | Immediately after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| statistical analysis | Sensitivity, specificity in predicting muscle invasive bladder cancer. | 1 day |
| positive predictive value (PPV), negative predictive value (NPV) | statistical analysis |
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Inclusion Criteria
Exclusion Criteria
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Patients with suspected bladder tumors due to symptoms such as hematuria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 1 day |
| the Receiver Operating Characteristic (ROC) curve | statistical analysis | 1 day |
| statistical analysis | the area under the curve (AUC) of the vi-rads score in predicting muscle invasive bladder cancer. | 1 day |