The Impact of PDD During TURB for NMIBC (TUR_BLUE)

A.O.U. Città della Salute e della Scienza

Status and phase: Not yet enrolling; Phase 4

Conditions: Bladder Cancer

Treatments: Procedure: Transurethral resection of the bladder performed with PDD tecnique and Hexvix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06548438

CDS01FS

Details and patient eligibility

About

The goal of this clinical trial is to learn if photodynamic diagnosis (PDD) performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg/50ml) is more sensitive than the standard white light tecnique in detection of malignant bladder tumour.

Patients will be randomised to:

• Transurethral resection of the bladder (TURB) with a standard white light tecnique
• TURB with the PDD tecnique using the study drug Hexvix

Full description

Non-muscle invasive pT1 high-grade (HG) bladder cancer (NIMBC) represents a challenge for the urologists due to its aggressive behavior, with a marked tendency to recur after transurethral resection of the bladder (TURB) and even progress to muscle-invasive disease. To limit the risk of upstaging and to provide more clinical information indispensable for the decision-making process, international guidelines strongly recommend a re-TURB to be performed within 2-6 weeks from the first resection in all pT1HG tumors. However, not all the published literature agrees on the value of re-TURB wich is also an invasive and morbid procedure, requires a general or locoregional anesthesia and, like all surgical procedure, it is not free of risks and complications. There is, therefore, an unmet need for improving the quality and completeness of TURB which may have an impact on the necessity of Re-TURB. It has been confirmed that fluorescence-guided biopsy and resection (photodynamic diagnosis-PDD) are more sensitive than conventional procedures for the detection of malignant tumours, particularly for CIS. PDD is performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg/50ml).To date, no randomized controlled trials (RCTs) have been conducted aiming to compare the completeness of TURB with PDD compared to TURB with standard white light (WL).

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntarily signed informed consent per Good Clinical Practice and national regulations
• Age ≥ 18 years
• Patient planned for TURB for >1,5 cm suspected (with either abdomen ultrasound or flexible cystoscopy) primary bladder cancer. The cut-off of 1,5cm has been chosen to maximize the probability of enrolling high-risk patients and, consequently, to maximize the probability of performing the re-TURB.

Exclusion criteria

• Patients with history of recurrent NMIBC
• Patients with visible incomplete resection during primary TURB
• Patients with metastatic disease or with a preoperative CT scan highly suspected for MIBC

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Photodynamic diagnosis using Hexvix

Experimental group

Description:

Transurethral resection of the bladder (TURB) is performed using photodynamic diagnosis (PDD) which involves the of use the study drug (Hexvix) to allow for better visualisation and subsequent resection

Treatment:

Procedure: Transurethral resection of the bladder performed with PDD tecnique and Hexvix

White light

No Intervention group

Description:

Transurethral resection of the bladder (TURB) is performed using the standard white light procedure