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NCT06337591 Clinical Trial

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

Bladder Cancer Clinical Trial

— VI-RADS  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06337591
Other study ID # INRCA_003_2024
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 15, 2022
Est. completion date March 10, 2024

Study information
Verified date March 2024
Source Istituto Nazionale di Ricovero e Cura per Anziani
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 10, 2024
Est. primary completion date March 10, 2024
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients with suspected primary bladder cancer at cystoscopy Exclusion Criteria: - Impaired renal function - claustrophobia - allergy to paramagnetic contrast agent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• VI-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.

Locations
Country Name City State
Italy AOU Hospital Ancona
Italy IRCCS INRCA Hospital Ancona
Italy Carlo Urbani Hospital Jesi

Sponsors (1)
Lead Sponsor Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection The 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. up to 12 weeks
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