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

NCT06337591 | Completed

• 1 other identifier: INRCA_003_2024
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Bladder Cancer

Keywords

bladder cancer; TURB; VI-RADS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patients with suspected primary bladder tumour (TV) at cystoscopy

Procedure: VI-RADS

Interventions

VI-RADS PROCEDURE

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.

patients with suspected primary bladder tumour (TV) at cystoscopy

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected primary bladder cancer

You may qualify if:

• patients with suspected primary bladder cancer at cystoscopy

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead

Study Sites (3)

AOU Hospital

Ancona, Italy

Location

IRCCS INRCA Hospital

Ancona, Italy

Location

Carlo Urbani Hospital

Iesi, Italy

Location

MeSH Terms

Conditions

Urinary 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

Study Officials

• Sara Cecchini, MD

  IRCCS INRCA, Ancona, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 29, 2024
• Study Start: October 15, 2022
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)