Radical CystectomyNCT05097404
Clinical Utility of VI-RADS in Diagnosis of MIBC
An observational study of Radical Cystectomy and Muscle-Invasive Bladder Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radical Cystectomy, Muscle-Invasive Bladder Carcinoma, Multiparametric MRI
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Sep 2021to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- history of TUR-BT
- previous radiation and/or chemotherapy for bladder cancer
- Not suitable for MRI or TUR-BT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Utility of Vesical Imaging Report and Data System (VI-RADS) in Diagnosis of Muscle Invasive Bladder Cancer
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of VI-RADS scoring system in diagnosis of MIBC
diagnostic accuracy of VI-RADS scoring system in diagnosis of MIBC
Measured: 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
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)
Measured: From Sep 2021 to Sep 2024
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)
Measured: From Sep 2021 to Sep 2024
Prediction of MIBC according to the VI-RADS scoring system
Prediction of MIBC according to the VI-RADS scoring system
Measured: From Sep 2021 to Sep 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start9 Sep 2021
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Radical CystectomyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097404
- Sponsor's protocol ID
- SamsungMC_UroRadiology
- Status last verified
- Sep 2021
- First submitted
- 27 Sep 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27370177Siegel 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.
PubMed 30620402Divrik 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.
PubMed 20303646Shindo 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.
PubMed 24190368Panebianco 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.
PubMed 29755006Pecoraro 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.
PubMed 32286874Del 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.
PubMed 31699526
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Vesical Imaging Report and Data System (VI-RADS) in Diagnosis of Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT05097404
- Acronym / sponsor ID
- SamsungMC_UroRadiology
- Conditions
- Radical Cystectomy, Muscle-Invasive Bladder Carcinoma, Multiparametric MRI, Vesical Imaging Report and Data System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- history of TUR-BT
- previous radiation and/or chemotherapy for bladder cancer
- Not suitable for MRI or TUR-BT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnostic accuracy of VI-RADS scoring system in diagnosis of MIBC
Time frame: From Sep 2021 to Sep 2024
diagnostic accuracy of VI-RADS scoring system in diagnosis of MIBC
3 secondary outcomes
clinical utility of VI-RADS to predict adverse pathology after repeat TUR-BT in high risk NMIBC
Time frame: From Sep 2021 to Sep 2024
clinical utility of VI-RADS to reduce unnecessary repeat TUR-BT in high risk NMIBC
Time frame: From Sep 2021 to Sep 2024
Prediction of MIBC according to the VI-RADS scoring system
Time frame: From Sep 2021 to Sep 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Background: PubMed 27370177Antoni 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.
- Background: PubMed 30620402Siegel 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.
- Background: PubMed 20303646Divrik 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.
- Background: PubMed 24190368Shindo 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.
- Background: PubMed 29755006Panebianco 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.
- Background: PubMed 32286874Pecoraro 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.
- Background: PubMed 31699526Del 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.
Related trials for Radical Cystectomy
Recruiting
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
Bladder Cancer
Active, not recruitingPhase 2
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Urinary Bladder Neoplasms
Not yet recruiting
Radical CystEctomy or RaDio-chEMotherapy as Preferred Treatment for invasivE blaDder Cancer
Muscle Invasive Bladder Cancer
Active, not recruitingEarly Phase 1
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
Bladder Cancer
Active, not recruiting
Mannitol Versus Nitroglycerin for Kidney Injury Prevention in Robotic-assisted Radical Prostatectomy or Cystectomy
Prostate Cancer, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radical Cystectomy and Muscle-Invasive Bladder Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy of VI-RADS scoring system in diagnosis of MIBC (time frame: From Sep 2021 to Sep 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05097404, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.