Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bladder Cancer, Urothelial Carcinoma (UC), Muscle Invasive Bladder Cancer (MIBC), Non Muscle Invasive Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer
Overview
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.
Detailed description
Accurate local staging is crucial for distinguishing non-muscle-invasive from muscle-invasive bladder cancer and guiding treatment decisions. While CT is widely used in clinical practice, MRI with VI-RADS has demonstrated higher diagnostic performance in previous retrospective and meta-analytic studies. However, prospective paired comparisons in the same patients are limited.
In this single-center prospective study, newly diagnosed bladder cancer patients undergo cystoscopy, contrast-enhanced CT, and multiparametric MRI prior to definitive histopathological sampling. Two radiologists independently assess imaging in a blinded research setting. Diagnostic performance of MRI and CT is compared using paired statistical analyses, with additional evaluation of interobserver agreement and tumor characteristics.
Primary outcome measures
- Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2) [Time frame: From imaging to final histopathological reference standard (up to 12 months)]
Secondary outcome measures (4)
- Positive and Negative Predictive Values [Time frame: From imaging to final histopathological reference standard (up to 12 months)]
- Interobserver Agreement for MRI and CT Tumor Staging [Time frame: During blinded image evaluation following imaging acquisition]
- Proportion of correctly classified Tumor T-stage (Ta-T4) by MRI and CT [Time frame: From imaging to final histopathological reference standard (up to 12 months)]
- Diagnostic accuracy of MRI and CT for detection of muscle-invasive bladder cancer within tumor subgroups [Time frame: From imaging to final histopathological reference standard (up to 12 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Norway · 1 center
- Oslo University Hospital — Oslo
Identifiers
NCT: NCT07602010 · 970903