MRI (VI-RADS) plus photodynamic-guided TURBT to avoid routine repeat bladder resections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional protocol enrolls adults with TUR-confirmed non‑muscle‑invasive bladder cancer who would otherwise be recommended a second-look resection. Participants receive preoperative multiparametric MRI scored with VI‑RADS and undergo primary photodynamic diagnosis (PDD)-assisted TURBT using hexaminolevulinate. Patients with low VI‑RADS (1–2) and a high-quality PDD-TURBT may avoid a planned Re‑TURBT, and outcomes such as residual tumor, recurrence, and pathological staging will be recorded. The study aims to determine whether the combined imaging-plus-PDD strategy can safely reduce unnecessary repeat resections and improve initial management.

Why it matters

Who can join: the full rules

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.

Where it's running

• AOU Policlinico Umberto I Hospital, UOC Urologia SMUC05, Rome, Italy
  Rome, Lazio, Italy Recruiting

Study contacts

• Study coordinator: Francesco Del Giudice, MD
• Email: francesco.delgiudice@uniroma1.it
• Phone: +39 3395382464

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.