Status:
NOT_YET_RECRUITING
The Impact of PDD During TURB for NMIBC
Lead Sponsor:
A.O.U. Città della Salute e della Scienza
Collaborating Sponsors:
Photocure
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 sensitiv...
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 o...
Eligibility Criteria
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 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06548438
Start Date
September 1 2024
End Date
September 1 2027
Last Update
August 12 2024
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