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

NCT07602010 | Recruiting

• 1 other identifier: 970903
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (4)

• Positive and Negative Predictive Values

  From imaging to final histopathological reference standard (up to 12 months)

• Interobserver Agreement for MRI and CT Tumor Staging

  During blinded image evaluation following imaging acquisition

• Proportion of correctly classified Tumor T-stage (Ta-T4) by MRI and CT

  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

  From imaging to final histopathological reference standard (up to 12 months)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Contraindications to MRI or iodinated contrast media
• Prior treatment for bladder cancer
• Pregnancy
• Non-malignant bladder lesions
• Tumors located in bladder diverticula

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Andreas Habberstad, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator, Department of Urology

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 22, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

NO (1)