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 (VI-RADS)

March 22, 2024 updated by: Istituto Nazionale di Ricovero e Cura per Anziani
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • IRCCS INRCA Hospital
      • Ancona, Italy
        • AOU Hospital
      • Jesi, Italy
        • Carlo Urbani Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected primary bladder cancer

Description

Inclusion Criteria:

  • patients with suspected primary bladder cancer at cystoscopy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with suspected primary bladder tumour (TV) at cystoscopy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection
Time Frame: up to 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Investigators

  • Principal Investigator: Sara Cecchini, MD, IRCCS INRCA, Ancona, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2022

Primary Completion (Actual)

March 10, 2024

Study Completion (Actual)

March 10, 2024

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INRCA_003_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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