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Muscle Invasive Bladder CancerVI-RADSNCT06807008

A Novel Pathway to Detect Muscle-invasive Bladder Cancer Based on Integrated Clinical Features and VI-RADS Score on MRI

An observational study of Muscle Invasive Bladder Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates the clinical, pathological, and radiological features, including the Vesical Imaging-Reporting and Data System (VI-RADS) score, that correlate with muscle-invasive bladder cancer (MIBC). It found that VI-RADS scores, along with other factors, were independent predictors of muscle invasiveness. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Muscle Invasive Bladder Cancer
How many people
139 participants
Where
4 sitesItaly
Study dates
1 Jan 2020to 31 May 2021
How long will I take part?
6 Weeks
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: This multicenter prospective observational study received formal approval from the Institutional Review Board and Ethics Committee of each participating center. All patients were informed of the experimental nature of this study and gave written informed consent. All patients with suspected BCa were referred to four different centers (Sapienza University of Rome [center #1], Istituto Nazionale Tumori "Regina Elena" in Rome [center #2], Azienda Ospedaliera Universitaria Santa Maria della Misericordia in Udine [center #3], and Azienda Ospedaliera Universitaria in Bologna [center #4]), between January 2020 and May 2021, and underwent bladder MRI.

Who may be able to join

  • a primary diagnosis of bladder tumor,
  • positive urinary cytology,
  • suspected bladder neoplasm identifed by ultrasound of the urinary tract and/or cystoscopy and/or CT scan of the abdomen-pelvis.

Who cannot join

  • history of prior urinary tract neoplasms,
  • impossibility of achieving appropriate bladder distension,
  • concomitant diagnosis of carcinoma in situ (CIS),
  • no detectable lesion on MRI
  • any contraindication to MRI (low renal function, MR unsafe medical devices etc.)
  • any contraindication to spinal and general anesthesia.

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, Bologna, 40138

  • AOU Policlinico Umberto I - Sapienza University of Rome

    Roma, Italy

  • Regina Elena" National Cancer Institute

    Roma, Italy

  • Santa Maria della Misericordia University Hospital in Udine

    Udine, Italy

Other trials in Italy

About this study

Official title: A Novel Pathway to Detect Muscle-invasive Bladder Cancer Based on Integrated Clinical Features and VI-RADS Score on MRI: Results of a Prospective Multicenter Study

This study investigates the clinical, pathological, and radiological features, including the Vesical Imaging-Reporting and Data System (VI-RADS) score, that correlate with muscle-invasive bladder cancer (MIBC). It found that VI-RADS scores, along with other factors, were independent predictors of muscle invasiveness.

Read the detailed description

The purpose of this study was to determine the clinical, pathological, and radiological features, including the Vesical Imaging-Reporting and Data System (VI-RADS) score, independently correlating with muscle-invasive bladder cancer (BCa), in a multicentric national setting. Patients with BCa suspicion were offered magnetic resonance imaging (MRI) before trans-urethral resection of bladder tumor (TURBT). According to VI-RADS, a cutoff of ≥ 3 or ≥ 4 was assumed to define muscle-invasive bladder cancer (MIBC). Trans-urethral resection of the tumor (TURBT) and/or cystectomy reports will be compared with preoperative VI-RADS scores to assess accuracy of MRI for discriminating between non-muscle-invasive versus MIBC. Performance will be assessed by ROC curve analysis. Two univariable and multivariable logistic regression models were implemented including clinical, pathological, radiological data, and VI-RADS categories to determine the variables with an independent effect on MIBC.

Keywords
Magnetic resonance imaging, VI-RADS, Muscle-invasive bladder cancer, Hematuria, Pathway
Medical subject headings
Hematuria

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The accuracy of the VI-RADS (Vesical Imaging-Reporting and Data System) score in predicting muscle-invasive bladder cancer (MIBC) preoperatively using MRI.

    In order to evaluate the diagnostic accuracy of the VI-RADS score in correctly differentiating non-muscle from muscle-invasive bladder disease at first diagnosis, diagnostic performance variables (sensitivity, specificity, accuracy, positive and negative predictive value, area under the curve, and ROC curves) will be calculated both overall over all participating centers and independently for different centers.

    The gold standard for differential diagnosis between NMIBC and MIBC will be represented by:

    • TURBT in those cases then classified as low-risk NMIBC;
    • Re-TURBT in those patients who are candidates for Re-TURBT according to the guidance provided by the EAU guidelines [14-15];
    • TURBT and/or radical cystectomy in those cases classified as MIBC (≥T2).

    Measured: 6 weeks

Secondary outcomes (1)

  1. The correlation between specific clinical features and MIBC.

    The correlation between specific clinical features (e.g., lesion size, presence of hydronephrosis) and MIBC. These factors were evaluated in conjunction with VI-RADS scores to refine diagnostic and predictive models

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start1 Jan 2020
  3. Primary completion31 May 2021
  4. Study completion31 May 2021

Resources

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
139 participants (actual)
Target duration
6 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT06807008
Sponsor's protocol ID
VI-RADS
Acronym
VI-RADS
Status last verified
Dec 2024
First submitted
10 Jan 2025
Last updated
4 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Muscle Invasive Bladder Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 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 3 inclusion and 6 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

The accuracy of the VI-RADS (Vesical Imaging-Reporting and Data System) score in predicting muscle-invasive bladder cancer (MIBC) preoperatively using MRI. (time frame: 6 weeks). 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 NCT06807008.

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 4 Feb 2025.

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