Testing a light-based scan to find bladder cancer during surgery
Tests a dye-and-violet-light method against standard surgery in adults with bladder cancer.
Plain-language title generated from the registry record
Registry title: The Impact of PDD During TURB for NMIBC
Key facts
- Where
- Turin, ItalySee the site
- Phase
- Phase 4
Where in Italy
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- A.O.U. Città della Salute e della Scienza
- Trial code
- NCT06548438EU 2024-514316-27-00
- Record updated
- 12 August 2024
- Original description
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.Read full original descriptionShow less
The Impact of PDD During TURB for NMIBC: a Prospective Randomized Controlled Trial
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
Inclusion: 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: Patients with visible incomplete resection during primary TURB; Patients with history of recurrent NMIBC; Patients with metastatic disease or with a preoperative CT scan highly suspected for MIBC.