Actively Recruiting
Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer
Led by Oslo University Hospital · Updated on 2026-05-22
150
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of computed tomography (CT) versus multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) for local staging of newly diagnosed bladder cancer. This study aims to improve the distinction between non-muscle-invasive and muscle-invasive bladder cancer, which is critical for guiding treatment decisions. Previous studies suggest MRI may have better diagnostic performance, but prospective comparisons in the same patients are limited. All participants receive both contrast-enhanced CT and multiparametric MRI scans before undergoing transurethral resection of the bladder tumor (TURBT) or cystectomy. Two radiologists independently review the imaging results without knowing each other's assessments or patient details. Imaging findings are then compared to biopsy or surgery results to determine the accuracy of each method. During the study, participants undergo cystoscopy and the two imaging tests prior to surgery. Researchers measure how well each imaging technique detects muscle-invasive bladder cancer and correctly classifies tumor stage over up to 12 months. They also assess agreement between radiologists and analyze tumor characteristics. The study helps understand which imaging method better supports treatment planning for bladder cancer.
CONDITIONS
Brief Title
Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Newly diagnosed bladder cancer confirmed by cystoscopy
- Planned transurethral resection of bladder tumor (TURBT) or cystectomy within 6 weeks
- Eligible for both CT and MRI scans within 6 weeks
- Provided written informed consent
You will not qualify if you...
- Contraindications to MRI or iodinated contrast media
- Prior treatment for bladder cancer
- Pregnancy
- Non-malignant bladder lesions
- Tumors located in bladder diverticula
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants undergo cystoscopy, contrast-enhanced CT, and multiparametric MRI (VI-RADS) as part of routine diagnostic work-up prior to surgical tumor resection.
1 to 3 visits depending on imaging and cystoscopy scheduling
Duration - Up to 12 months
Participants are monitored for up to 12 months to compare imaging results with histopathological findings from surgery for diagnostic accuracy assessment.
Follow-up visits according to standard care
Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway
Actively Recruiting
Research Team
S
Study Coordinator, Department of Urology
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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