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Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Roma La Sapienza
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In plain words

What the trial is, and whether it could suit you

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 delivered. As such, performing TURBT with standard white light (WL) cystoscopy is known to miss many bla

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📋 Eligibility rules (as published)
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 MIBC (i.e., T2) or locally advanced BCa (i.e., T3-T4). 3. Preoperative evidence of metastatic disease (i.e., cN1 - N3 and/or cM1). 4. Visual evidence of low-risk NMIBC (solitary tumor, \< 1 cm) before initial TURBT. 5. Visual evidence of MIBC on preliminary cystoscopy (i.e., non-papillary or sessile mass attached directly by its base without a stalk). 6. TURBT diagnosis of NMIBCs not eligible for Re-TURBT according to EAU Guidelines (i.e., Ta-LG; Ta-HG with detrusor muscle in the specimen; primary CIS) \[6\]. 7. Concomitant Upper tract (kidney or ureteric) tumours on imaging. 8. Contraindication to adjuvant intravesical BCG immunotherapy. 9. Unfit to undergo any procedures listed in protocol.
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What it tests

  • PDD-TURBT with hexaminolevulinate (Hexvix®)
  • Power Led Saphira (TM)
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Where

1 site
AOU Policlinico Umberto I Hospital, UOC Urologia SMUC05, Rome, Italy
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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