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)

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

327

Participants

Timeline

Start Date

January 31, 2026

Primary Completion Date

December 31, 2027

Study Completion Date

February 28, 2030

Conditions
Non-muscle-invasive Bladder CancerNon-Muscle Invasive Bladder Urothelial CarcinomaHigh Risk Non-Muscle Invasive Bladder Urothelial Carcinoma
Interventions
DRUG

PDD-TURBT with hexaminolevulinate (Hexvix®)

In order to undergo PDD-TURBT, all eligible patients in the experimental arm will be administered the photosensitizer hexaminolevulinate (85 mg in 50 ml of phosphate buffered saline, Hexvix®) on an inpatient setting through a urethral catheterization of the participant's bladder. During the PDD-TURBT surgery, the bladder will be illuminated with blue light (wavelength 380-450 nm). The operating rooms of the participant institutions will therefore need to have the specialized equipment consisting in the blue-light source (POWER LED SAPHIRA \[TM\]).

DEVICE

Power Led Saphira (TM)

This is a light source based on LED technology. It can be used for both White Light (WL) and fluorescence applications in blue light (i.e., Photodynamic diagnosis PDD) for visualizing tumor lesions during trans-urethral resection of bladder tumors (PPD- TURBT).

All Listed Sponsors
lead

University of Roma La Sapienza

OTHER