Clinical trial · Observational
A Novel Pathway to Detect Muscle-invasive Bladder Cancer Based on Integrated Clinical Features and VI-RADS Score on MRI
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
NCT06807008CI-TRIAL-00085486VI-RADScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The accuracy of the VI-RADS (Vesical Imaging-Reporting and Data System) score in predicting muscle-invasive bladder cancer (MIBC) preoperatively using MRI.
- timeFrame
- 6 weeks
- description
- 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 outcomes (1)
- measure
- The correlation between specific clinical features and MIBC.
- timeFrame
- 6 weeks
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.