Clinical Utility of VI-RADS in Diagnosis of MIBC

NCT05097404 | Unknown

• 1 other identifier: SamsungMC_UroRadiology
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 reduce unnecessary repeat TUR-BT in high risk NMIBC

  From Sep 2021 to Sep 2024

• Prediction of MIBC according to the VI-RADS scoring system

  From Sep 2021 to Sep 2024

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• history of TUR-BT
• previous radiation and/or chemotherapy for bladder cancer
• Not suitable for MRI or TUR-BT

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (7)

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  PMID: 27370177 BACKGROUND

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8.

  PMID: 30620402 BACKGROUND

• Divrik RT, Sahin AF, Yildirim U, Altok M, Zorlu F. Impact of routine second transurethral resection on the long-term outcome of patients with newly diagnosed pT1 urothelial carcinoma with respect to recurrence, progression rate, and disease-specific survival: a prospective randomised clinical trial. Eur Urol. 2010 Aug;58(2):185-90. doi: 10.1016/j.eururo.2010.03.007. Epub 2010 Mar 19.

  PMID: 20303646 BACKGROUND

• Shindo T, Masumori N, Kitamura H, Tanaka T, Fukuta F, Hasegawa T, Yanase M, Miyake M, Miyao N, Takahashi A, Matsukawa M, Taguchi K, Shigyo M, Kunishima Y, Tachiki H, Tsukamoto T. Clinical significance of definite muscle layer in TUR specimen for evaluating progression rate in T1G3 bladder cancer: multicenter retrospective study by the Sapporo Medical University Urologic Oncology Consortium (SUOC). World J Urol. 2014 Oct;32(5):1281-5. doi: 10.1007/s00345-013-1205-1. Epub 2013 Nov 5.

  PMID: 24190368 BACKGROUND

• Panebianco V, Narumi Y, Altun E, Bochner BH, Efstathiou JA, Hafeez S, Huddart R, Kennish S, Lerner S, Montironi R, Muglia VF, Salomon G, Thomas S, Vargas HA, Witjes JA, Takeuchi M, Barentsz J, Catto JWF. Multiparametric Magnetic Resonance Imaging for Bladder Cancer: Development of VI-RADS (Vesical Imaging-Reporting And Data System). Eur Urol. 2018 Sep;74(3):294-306. doi: 10.1016/j.eururo.2018.04.029. Epub 2018 May 10.

  PMID: 29755006 BACKGROUND

• Pecoraro M, Takeuchi M, Vargas HA, Muglia VF, Cipollari S, Catalano C, Panebianco V. Overview of VI-RADS in Bladder Cancer. AJR Am J Roentgenol. 2020 Jun;214(6):1259-1268. doi: 10.2214/AJR.20.22763. Epub 2020 Apr 14.

  PMID: 32286874 BACKGROUND

• Del Giudice F, Barchetti G, De Berardinis E, Pecoraro M, Salvo V, Simone G, Sciarra A, Leonardo C, Gallucci M, Catalano C, Catto JWF, Panebianco V. Prospective Assessment of Vesical Imaging Reporting and Data System (VI-RADS) and Its Clinical Impact on the Management of High-risk Non-muscle-invasive Bladder Cancer Patients Candidate for Repeated Transurethral Resection. Eur Urol. 2020 Jan;77(1):101-109. doi: 10.1016/j.eururo.2019.09.029. Epub 2019 Nov 5.

  PMID: 31699526 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 28, 2021
• Study Start: September 9, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 28, 2021

Record last verified: 2021-09

Locations

KR (1)