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

Completed

• Conditions: Muscle Invasive Bladder Cancer

• Registration Number: NCT06807008
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2024-12
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The correlation between specific clinical features and MIBC.	6 weeks	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

Trial Locations

Locations (4)

Santa Maria della Misericordia University Hospital in Udine; 🇮🇹 Udine, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy

AOU Policlinico Umberto I - Sapienza University of Rome; 🇮🇹 Roma, Italy

Regina Elena" National Cancer Institute; 🇮🇹 Roma, Italy