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Clinical Utility of VI-RADS in Diagnosis of MIBC

Samsung Medical Center logo

Samsung Medical Center

Status

Active, not recruiting

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT05097404
SamsungMC_UroRadiology

Details and patient eligibility

About

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.

Enrollment

73 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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