Bladder CancerVI-RADSNCT06337591
Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location
An observational study of Bladder Cancer, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in Italy.
Trial summary
VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- VI-RADS
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Oct 2022to 10 Mar 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with suspected primary bladder cancer
Who may be able to join
- patients with suspected primary bladder cancer at cystoscopy
Who cannot join
- Impaired renal function
- claustrophobia
- allergy to paramagnetic contrast agent
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
AOU Hospital
Ancona
IRCCS INRCA Hospital
Ancona
Carlo Urbani Hospital
Iesi
About this study
VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.
Read the detailed description
The VI-RADS (bladder imaging-reporting and data system) scoring system is an imaging tool that can help distinguish non-muscle-invasive from muscle-invasive disease prior to transurethral resection (TURB). The VI-RADS consists of a five-point scoring system based on the assessment of tumour size, morphology, growth, degree of restriction and contrast capture to assess the likelihood of bladder wall invasion. VI-RADS was an observational, prospective, multicenter, no profit study. The aims of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.
- Conditions
- Bladder Cancer
- Being tested
- VI-RADS
- Keywords
- bladder cancer, TURB, VI-RADS
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VI-RADSProcedure or surgery
Patients with suspected bladder cancer underwent multiparametric magnetic resonance imaging (mMRI) and vescical imaging reporting and data system (VI-RADS) score calculation. After trans-urethral resection of bladder (TURB), the results of biopsy were compared to the VI-RADS score to verify their concordance.
| Study group | Role | What they receive |
|---|---|---|
| patients with suspected primary bladder tumour (TV) at cystoscopy | Not described Receives: Procedure: VI-RADS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection
The sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in muscle invasion will be evaluated by comparing the score of VI-RADS with the results of biopsy after transurethral resection of bladder cancer.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start15 Oct 2022
- Primary completion10 Mar 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Cecchini, MD, Principal investigator, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337591
- Sponsor's protocol ID
- INRCA_003_2024
- Acronym
- VI-RADS
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location
- ClinicalTrials.gov ID
- NCT06337591
- Acronym / sponsor ID
- VI-RADS / INRCA_003_2024
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, TURB, VI-RADS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 29 Mar 2024 (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.
VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.
Detailed description
The VI-RADS (bladder imaging-reporting and data system) scoring system is an imaging tool that can help distinguish non-muscle-invasive from muscle-invasive disease prior to transurethral resection (TURB). The VI-RADS consists of a five-point scoring system based on the assessment of tumour size, morphology, growth, degree of restriction and contrast capture to assess the likelihood of bladder wall invasion. VI-RADS was an observational, prospective, multicenter, no profit study. The aims of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with suspected primary bladder tumour (TV) at cystoscopy | – | Procedure: VI-RADS |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected primary bladder cancer
Key inclusion criteria (1 listed)
- patients with suspected primary bladder cancer at cystoscopy
Key exclusion criteria (3 listed)
- Impaired renal function
- claustrophobia
- allergy to paramagnetic contrast agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VI-RADSPatients with suspected bladder cancer underwent multiparametric magnetic resonance imaging (mMRI) and vescical imaging reporting and data system (VI-RADS) score calculation. After trans-urethral resection of bladder (TURB), the results of biopsy were compared to the VI-RADS score to verify their concordance. | Procedure or surgery | patients with suspected primary bladder tumour (TV) at cystoscopy |
Primary outcome
Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection
Time frame: up to 12 weeks
The sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in muscle invasion will be evaluated by comparing the score of VI-RADS with the results of biopsy after transurethral resection of bladder cancer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Sara Cecchini, MD principal investigator
IRCCS INRCA, Ancona, Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in Italy.
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 1 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: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2024.