This prospective diagnostic accuracy study compares computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) for local staging of newly diagnosed bladder cancer. All participants undergo both imaging modalities prior to transurethral resection of the bladder tumor (TURBT) or cystectomy. Histopathology serves as the reference standard.
Age ≥ 18 years
Newly diagnosed bladder cancer on cystoscopy
Planned TURBT or cystectomy within 6 weeks
Eligible for both CT and MRI within 6 weeks
Contraindications to MRI or iodinated contrast media
Prior treatment for bladder cancer
Pregnancy
Non-malignant bladder lesions
The study population consists of adult patients with newly diagnosed bladder cancer identified on cystoscopy at a tertiary referral hospital. Eligible participants are patients planned for transurethral resection of the bladder tumor (TURBT) and/or cystectomy as part of standard clinical care, and who are able to undergo both contrast-enhanced computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) prior to definitive histopathological assessment. Patients are included irrespective of tumor stage or grade at presentation, provided that imaging is performed within the defined preoperative diagnostic pathway. Patients with prior bladder cancer treatment or contraindications to imaging are excluded.
Cohort
Prospective
Not listed
Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2)
The primary outcome is the diagnostic accuracy of multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) compared with contrast-enhanced computed tomography (CT) for the detection of muscle-invasive bladder cancer (pathological stage ≥T2). Sensitivity and specificity will be calculated using histopathology from transurethral resection of the bladder tumor, re-TURBT, and/or cystectomy as the reference standard.
Positive and Negative Predictive Values
Positive predictive value (PPV) and negative predictive value (NPV) of MRI (VI-RADS) and CT for detection of muscle-invasive bladder cancer (≥T2), calculated using histopathology as the reference standard.
Interobserver Agreement for MRI and CT Tumor Staging
Interobserver agreement between two independent radiologists for MRI VI-RADS scoring and CT-based T-stage assessment, quantified using weighted kappa statistics in a blinded research reading setting.
Proportion of correctly classified Tumor T-stage (Ta-T4) by MRI and CT
Proportion of correctly classified tumor T-stage (Ta-T4) by MRI and CT compared with histopathological staging from TURBT and/or cystectomy.
Diagnostic accuracy of MRI and CT for detection of muscle-invasive bladder cancer within tumor subgroups
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MRI and CT for detection of muscle-invasive bladder cancer, assessed within predefined tumor subgroups (tumor size, morphology, tumor location and multiplicity), using histopathology as the reference standard.
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