Can VI-RADS/ADC Accurately Stage Bladder Cancer??

Study Overview
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Brief Summary
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Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).

Detailed Description
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Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC). We aim to examine the accuracy of VI-RADS for predicting MIBC in final histopathology specimen. To assess whether incorporating ADC into VI-RADS improves the MIBC predictive accuracy of VI-RADS

Official Title
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Can Vesical Imaging-Reporting And Data System and Apparent Diffusion Coefficient Values (the VI-RADS/ADC) Accurately Predict Non-Muscle Invasive Bladder Cancer

Conditions
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Bladder Disease, MRI Contrast Media Adverse Reaction, Bladder Cancer, Bladder Neoplasm, Bladder Urothelial Carcinoma, Bladder Cancer Stage, Diagnoses Disease

Intervention / Treatment
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* Radiation: Multi-parametric MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed at the out-patient cystoscopy with papillary or small nodular bladder tumour Exclusion Criteria: fungating lesions beyond the scope of enbloc resection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multiparametric MRI<br>Vesical Imaging-Reporting And Data System (VI-RADS) using multi-parametric MRI. | Radiation: Multi-parametric MRI<br>* Vesical Imaging-Reporting And Data System (VI-RADS) for predicting non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.<br>* Other names: MP-MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vesical Imaging-Reporting And Data System (VI-RADS) for discriminating muscle invasive bladder cancer (MIBC) from non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI. | assessed by final histopathology specimen retrieved by enbloc transurethral resection of bladder tumors (ERBT) | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VI-RADS, Multiparametric MRI, Non-muscle invasive bladder cancer (NMIBC), Muscle invasive bladder cancer (MIBC)