Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging

University of Oslo (UIO)

Status: Enrolling

Conditions: Bladder Cancer; Muscle Invasive Bladder Cancer (MIBC); Urothelial Carcinoma (UC); Non Muscle Invasive Bladder Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07602010

970903

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

150 participants in 1 patient group

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.