Clinical Utility of VI-RADS in Diagnosis of MIBC

Muscle-Invasive Bladder Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05097404
• Other study ID #: SamsungMC_UroRadiology
• Status: Active, not recruiting
• Start date: September 9, 2021
• Est. completion date: September 2024

Study information

• Verified date: September 2021
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 73
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiparametric MRI
• Muscle-Invasive Bladder Carcinoma
• Radical Cystectomy
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

Antoni S, Ferlay J, Soerjomataram I, Znaor A, Jemal A, Bray F. Bladder Cancer Incidence and Mortality: A Global Overview and Recent Trends. Eur Urol. 2017 Jan;71(1):96-108. doi: 10.1016/j.eururo.2016.06.010. Epub 2016 Jun 28. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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