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Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location

Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06337591
Acronym
VI-RADS
Enrollment
20
Registered
2024-03-29
Start date
2022-10-15
Completion date
2024-03-10
Last updated
2024-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

bladder cancer, TURB, VI-RADS

Brief summary

VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.

Detailed description

The VI-RADS (bladder imaging-reporting and data system) scoring system is an imaging tool that can help distinguish non-muscle-invasive from muscle-invasive disease prior to transurethral resection (TURB). The VI-RADS consists of a five-point scoring system based on the assessment of tumour size, morphology, growth, degree of restriction and contrast capture to assess the likelihood of bladder wall invasion. VI-RADS was an observational, prospective, multicenter, no profit study. The aims of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.

Interventions

PROCEDUREVI-RADS

Patients with suspected bladder cancer underwent multiparametric magnetic resonance imaging (mMRI) and vescical imaging reporting and data system (VI-RADS) score calculation. After trans-urethral resection of bladder (TURB), the results of biopsy were compared to the VI-RADS score to verify their concordance.

Sponsors

Istituto Nazionale di Ricovero e Cura per Anziani
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* patients with suspected primary bladder cancer at cystoscopy

Exclusion criteria

* Impaired renal function * claustrophobia * allergy to paramagnetic contrast agent

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resectionup to 12 weeksThe sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in muscle invasion will be evaluated by comparing the score of VI-RADS with the results of biopsy after transurethral resection of bladder cancer.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026