The Impact of PDD During TURB for NMIBC
ConditionBladder Cancer
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorA.O.U. Città della Salute e della Scienza
About this 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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Treatments tested in this trial
- Transurethral resection of the bladder performed with PDD tecnique and Hexvix
Treatment groups
300 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
A.O.U. Città della Salute e della Scienza
Lead sponsor
Photocure
Collaborator
Source ClinicalTrials.gov