The Impact of PDD During TURB for NMIBC

Trial Title: The Impact of PDD During TURB for NMIBC

NCT ID: NCT06548438

Condition: Bladder Cancer

Conditions: Official terms:
Urinary Bladder Neoplasms

Conditions: Keywords:
TURB
re-TURB
photodynamic diagnosis-PDD
Hexvix

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomised controlled trial. Randomization will be stratified based on the dedicated surgeon performing the procedure. Allocation will be at a 1:1 ratio between the two arms

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Transurethral resection of the bladder performed with PDD tecnique and Hexvix
Description: For the execution of PDD cystoscopy in blue light, it is necessary to use the study drug (Hexvix) which, after intravesical instillation, causes an accumulation of porphyrins in the lesions of the bladder wall at the intracellular level. The intracellular porphyrins are photoactive fluorescent compounds that emit red light when excited with blue light. Consequently, the preneoplastic and neoplastic lesions will emit a red luminescence against a blue background, allowing for better visualisation and subsequent resection.
Arm group label: Photodynamic diagnosis using Hexvix

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).

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: September 1, 2024

Completion date: September 1, 2027

Lead sponsor:
Agency: A.O.U. Città della Salute e della Scienza
Agency class: Other

Collaborator:
Agency: Photocure
Agency class: Industry

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

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06548438