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

May 15, 2026 updated by: Andreas Habberstad, Oslo University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Study Coordinator, Department of Urology
  • Phone Number: +47 22 89 40 00
  • Email: postmottak@ous-hf.no

Study Locations

  • Norway
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital
        • Contact:
          • Study Coordinator, Department of Urology
          • Phone Number: +47 22 89 40 00
          • Email: postmottak@ous-hf.no
        • Principal Investigator:
          • Andreas Habberstad, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients with newly diagnosed bladder cancer identified on cystoscopy at a tertiary referral hospital. Eligible participants are patients planned for transurethral resection of the bladder tumor (TURBT) and/or cystectomy as part of standard clinical care, and who are able to undergo both contrast-enhanced computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) prior to definitive histopathological assessment.

Patients are included irrespective of tumor stage or grade at presentation, provided that imaging is performed within the defined preoperative diagnostic pathway. Patients with prior bladder cancer treatment or contraindications to imaging are excluded.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Imaging Comparison Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From imaging to final histopathological reference standard (up to 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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)
Proportion of correctly classified tumor T-stage (Ta-T4) by MRI and CT compared with histopathological staging from TURBT and/or cystectomy.
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)
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.
From imaging to final histopathological reference standard (up to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Andreas Habberstad, MD, PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

May 9, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 970903

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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