Clinical Utility of VI-RADS in Diagnosis of MIBC

Active, not recruiting

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

• Registration Number: NCT05097404
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-09
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-10-24
• Last Update Submitted: 2021-10-24
• Study First Posted: 2021-10-28
• Last Update Posted: 2021-10-28
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy of VI-RADS scoring system in diagnosis of MIBC	From Sep 2021 to Sep 2024	diagnostic accuracy of VI-RADS scoring system in diagnosis of MIBC

Secondary Outcome Measures

Name	Time	Method
clinical utility of VI-RADS to predict adverse pathology after repeat TUR-BT in high risk NMIBC	From Sep 2021 to Sep 2024	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)
clinical utility of VI-RADS to reduce unnecessary repeat TUR-BT in high risk NMIBC	From Sep 2021 to Sep 2024	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)
Prediction of MIBC according to the VI-RADS scoring system	From Sep 2021 to Sep 2024	Prediction of MIBC according to the VI-RADS scoring system

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of