The Impact of PDD During TURB for NMIBC
- Conditions
- Bladder Cancer
- Interventions
- Procedure: Transurethral resection of the bladder performed with PDD tecnique and Hexvix
- Registration Number
- NCT06548438
- Lead Sponsor
- A.O.U. Città della Salute e della Scienza
- Brief Summary
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
- Detailed 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Photodynamic diagnosis using Hexvix Transurethral resection of the bladder performed with PDD tecnique and Hexvix 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
- Primary Outcome Measures
Name Time Method Residual disease and/or upstaging 6 to 8 weeks from the intervention Compare the completeness of TURB with PDD vs TURB with WL in terms of proportion of patients with residual disease and/or upstaging at re-TURB
- Secondary Outcome Measures
Name Time Method Number of Participants diagnosed with malignant lesions 6 to 8 weeks from the intervention Compare the detection of malignant lesions between PDD and WLC using high-definition (HD) equipment during both primary TURB and re-TURB
The European organization for reasearch and treatment of cancer quality of life questionnaire for patients with non-muscle invasive bladder cancern from date of randomization until 20 weeks from randomization The scale range from 24 (better outcome) to 96 (worse outcome)
Adverse events from date of randomization until 20 weeks from randomization Assess treatment changes and adverse events associated with each technique
EQ-5D-5L from date of randomization until 20 weeks from randomization The scale range from 5 (better outcome) to 25 (worse outcome)
EQ VAS from date of randomization until 20 weeks from randomization A self-rating question of overall health status, measured on a 0 (worse outcome) to 100 (better outcome) visual analogue scale