Clinical trial · Observational
Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging
Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Muscle Invasive Bladder Cancer (MIBC) | — | UNRESOLVED | — |
| Non Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
| Urothelial Carcinoma (UC) | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Imaging Comparison Group
- description
- All participants undergo contrast-enhanced CT and multiparametric MRI (VI-RADS) as part of routine diagnostic work-up prior to transurethral resection of the bladder tumor or cystectomy. Imaging findings are compared with histopathology for assessment of diagnostic accuracy.
Primary outcomes (1)
- measure
- Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2)
- timeFrame
- From imaging to final histopathological reference standard (up to 12 months)
- description
- 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.
Secondary outcomes (4)
- measure
- Positive and Negative Predictive Values
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Written informed consent provided Exclusion Criteria: * Contraindications to MRI or iodinated contrast media * Prior treatment for bladder cancer * Pregnancy * Non-malignant bladder lesions * Tumors located in bladder diverticula
References
Publications (0)
Data not yet available