Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethra
Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer b
| Condition(s) | Non-muscle-invasive Bladder Cancer, Non-Muscle Invasive Bladder Urothelial Carcinoma, High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment. Currently, no diagnostic strategy or predictive tools have been implemented to further stratify who does or does not benefit from Re-TURBT. Recently, an MRI-based Vesical Imaging Reporting and Data System (VI-RADS) score has been developed to stage as to the preoperative probability of muscle invasion, which could potentially exclude those who do not require a Re-TURBT when a primary high-quality resection is deli |
| Who can participate | Inclusion Criteria: 1. Female and Male patients at least 18 years old referred for clinical suspicion of primary or recurrent BCa who have been advised to undergo TURBT. 2. Patients with a TUR-confirmed diagnosis of NMIBC and candidate for second look and resection (Re-TURBT) according to EAU Guidelines \[6\]. 3. No imaging evidence (i.e., mpMRI/VI-RADS score 1 or 2) of muscle-invasive, locally advanced, or metastatic BCa (i.e., only confirmed CIS, Ta, T1, N0, M0 will be considered eligible). 4. Patients who did or did not receive previous BCG immunotherapy (i.e., BCG naïve and non-naïve patients). 5. Fit to undergo all procedures listed in protocol. 6. Able to provide written informed consent. Exclusion Criteria: 1. Contraindication to TURBT and/or Re-TURBT. 2. Initial TURBT diagnosis of |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Roma La Sapienza |
| Locations | Rome, Lazio, Italy |
| Start date | 2025-12-22 |
| NCT ID | NCT05962541 |
| Official listing | https://clinicaltrials.gov/study/NCT05962541 |