The Impact of PDD During TURB for NMIBC

Last updated: August 7, 2024
Sponsor: A.O.U. Città della Salute e della Scienza
Overall Status: Active - Not Recruiting

Phase

4

Condition

Bladder Cancer

Urothelial Cancer

Urothelial Carcinoma

Treatment

Transurethral resection of the bladder performed with PDD tecnique and Hexvix

Clinical Study ID

NCT06548438
CDS01FS
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntarily signed informed consent per Good Clinical Practice and nationalregulations

  • Age ≥ 18 years

  • Patient planned for TURB for >1,5 cm suspected (with either abdomen ultrasound orflexible cystoscopy) primary bladder cancer. The cut-off of 1,5cm has been chosen tomaximize the probability of enrolling high-risk patients and, consequently, tomaximize the probability of performing the re-TURB.

Exclusion

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 forMIBC

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Transurethral resection of the bladder performed with PDD tecnique and Hexvix
Phase: 4
Study Start date:
September 01, 2024
Estimated Completion Date:
September 01, 2027

Study 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).