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NCT Number: NCT07602010

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

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.

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Key information

Conditions

Bladder Cancer Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Muscle Invasive Bladder Cancer (MIBC) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non Muscle Invasive Bladder Cancer Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma (UC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, Norway

Location status: Recruiting

Location contact

Andreas Habberstad, MD, PhD

PRINCIPAL_INVESTIGATOR

Study Coordinator, Department of Urology

CONTACT

[email protected]

+47 22 89 40 00

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2)

    Time frame: 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 outcomes

  1. Positive and Negative Predictive Values

    Time frame: 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.

  2. Interobserver Agreement for MRI and CT Tumor Staging

    Time frame: 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.

  3. 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)

    Proportion of correctly classified tumor T-stage (Ta-T4) by MRI and CT compared with histopathological staging from TURBT and/or cystectomy.

  4. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator, Department of Urology

CONTACT

[email protected]

+47 22 89 40 00

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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