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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

NCT ID: NCT06337591

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-15

Study Completion Date

2024-03-10

Brief Summary

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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

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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.

Conditions

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Bladder Cancer

Keywords

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bladder cancer TURB VI-RADS

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with suspected primary bladder tumour (TV) at cystoscopy

VI-RADS

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with suspected primary bladder cancer at cystoscopy

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sara Cecchini, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS INRCA, Ancona, Italy

Locations

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AOU Hospital

Ancona, , Italy

Site Status

IRCCS INRCA Hospital

Ancona, , Italy

Site Status

Carlo Urbani Hospital

Iesi, , Italy

Site Status

Countries

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Italy

Other Identifiers

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INRCA_003_2024

Identifier Type: -

Identifier Source: org_study_id