Clinical Utility of VI-RADS in Diagnosis of MIBC

Study Overview
=================
Brief Summary
-----------------
Bladder Cancer (BCa) is the 9th most common cancer worldwide. In general, BCa is presented as a non-muscle invasive bladder cancer (NMIBC) in 70% of patients and treated with transurethral resection of bladder tumor (TUR-BT). However, in cases of muscle invasive bladder cancer (MIBC), radical cystectomy (RC) is the gold standard of treatment. Therefore, It is important to distinguish MIBC from NMIBC. To date, pathologic staging is based on the result of TUR-BT before RC. However, it is operator dependent, thus residual cancer may be remained depending on surgical experience. Therefore, about 7%-30% patients of MIBC can be underestimated with NMIBC, and it can be increased to 45% if the muscle is not resected. Consequently, it has been raised the need for imaging test to overcome diagnostic limitations. Multiparametric magnetic resonance imaging (mpMRI) has been widely used in the field of diagnosis of BCa. In 2018, the Vesical Imaging Report and Data System (VI-RADS) was published using T2-weighted imaging (T2WI), diffusion-weighted imaging (DWI), and dynamic contrast enhanced (DCE) imaging, and 5-point VI-RADS scoring system has been proposed and reported as an imaging test useful for assessing muscle involvement in primary bladder cancer Therefore, in this study, we investigate the diagnostic performance of the VI-RADS scoring system that can differentiate NMIBC from MIBC in primary bladder cancer.

Official Title
-----------------
Clinical Utility of Vesical Imaging Report and Data System (VI-RADS) in Diagnosis of Muscle Invasive Bladder Cancer

Conditions
-----------------
Radical Cystectomy, Muscle-Invasive Bladder Carcinoma, Multiparametric MRI, Vesical Imaging Report and Data System

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years primary bladder cancer in cystoscopy suitable for MRI and TUR-BT agreement to participate in the study and signing of an informed consent form Exclusion Criteria: history of TUR-BT previous radiation and/or chemotherapy for bladder cancer Not suitable for MRI or TUR-BT

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of VI-RADS scoring system in diagnosis of MIBC | diagnostic accuracy of VI-RADS scoring system in diagnosis of MIBC | From Sep 2021 to Sep 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical utility of VI-RADS to predict adverse pathology after repeat TUR-BT in high risk NMIBC | clinical utility of VI-RADS to predict MIBC after repeat TUR-BT in high risk NMIBC (To predict the chance of MIBC after repeat TUR-BC according to VI-RADS score in patients with high risk MNIBC) | From Sep 2021 to Sep 2024 | 
| clinical utility of VI-RADS to reduce unnecessary repeat TUR-BT in high risk NMIBC | clinical utility of VI-RADS to reduce unnecessary repeat TUR-BT in high risk NMIBC (To predict the chance of NMIBC after repeat TUR-BC according to VI-RADS score in patients with high risk MNIBC) | From Sep 2021 to Sep 2024 | 
| Prediction of MIBC according to the VI-RADS scoring system | Prediction of MIBC according to the VI-RADS scoring system | From Sep 2021 to Sep 2024 |