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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

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.