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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07602010

Enrollment

150

Registered

2026-05-22

Start date

2026-04-22

Completion date

2028-10-31

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Muscle Invasive Bladder Cancer (MIBC), Non Muscle Invasive Bladder Cancer, Urothelial Carcinoma (UC)

Keywords

MRI, Computed Tomography, VI-RADS, Local Staging, Diagnostic Accuracy

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2)	From imaging to final histopathological reference standard (up to 12 months)	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

Measure	Time frame	Description
Positive and Negative Predictive Values	From imaging to final histopathological reference standard (up to 12 months)	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	During blinded image evaluation following imaging acquisition	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	From imaging to final histopathological reference standard (up to 12 months)	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	From imaging to final histopathological reference standard (up to 12 months)	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.

Countries

Norway

Contacts

CONTACTStudy Coordinator, Department of Urology

postmottak@ous-hf.no+47 22 89 40 00

PRINCIPAL_INVESTIGATORAndreas Habberstad, MD, PhD

Oslo University Hospital

Outcome results