Clinical trial NCT05097404: Clinical Utility of VI-RADS in Diagnosis of MIBC
Official title: Clinical Utility of Vesical Imaging Report and Data System (VI-RADS) in Diagnosis of Muscle Invasive Bladder Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radical Cystectomy
Muscle-Invasive Bladder Carcinoma
Multiparametric MRI
Vesical Imaging Report and Data System
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary bladder cancer Healthy suitable to perform multiparametric MRI pre-operatively Perform TUR-BT that has been sufficiently implemented to check for muscle invasion

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.


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

Primary outcomes:
measure: diagnostic accuracy of VI-RADS scoring system in diagnosis of MIBC
timeFrame: From Sep 2021 to Sep 2024
Secondary outcomes:
measure: clinical utility of VI-RADS to predict adverse pathology after repeat TUR-BT in high risk NMIBC
timeFrame: From Sep 2021 to Sep 2024
measure: clinical utility of VI-RADS to reduce unnecessary repeat TUR-BT in high risk NMIBC
timeFrame: From Sep 2021 to Sep 2024
measure: Prediction of MIBC according to the VI-RADS scoring system
timeFrame: From Sep 2021 to Sep 2024
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
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