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

NCT06807008 | Completed

• 1 other identifier: VI-RADS
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Muscle Invasive Bladder Cancer

Keywords

Magnetic resonance imaging; VI-RADS; Muscle-invasive bladder cancer; Hematuria; Pathway

Outcome Measures

Primary Outcomes (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).

  6 weeks

Secondary Outcomes (1)

• The correlation between specific clinical features and MIBC.

  6 weeks

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (4)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

AOU Policlinico Umberto I - Sapienza University of Rome

Roma, Italy, Italy

Location

Regina Elena" National Cancer Institute

Roma, Italy, Italy

Location

Santa Maria della Misericordia University Hospital in Udine

Udine, Italy, Italy

Location

MeSH Terms

Conditions

Hematuria

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Riccardo Schiavina, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 4, 2025
• Study Start: January 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: February 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)