Muscle Invasive Bladder Cancer
Conditions
Keywords
Magnetic resonance imaging, VI-RADS, Muscle-invasive bladder cancer, Hematuria, Pathway
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed