Menu
Not yet recruiting NCT06548438

The Impact of PDD During TURB for NMIBC

Phase IV Interventional Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transurethral resection of the bladder performed with PDD tecnique and Hexvix.
Who it may be relevant to
Registry conditions: Bladder Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Impact of PDD During TURB for NMIBC: a Prospective Randomized Controlled Trial

Overview

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).

Interventions

  • Procedure Transurethral resection of the bladder performed with PDD tecnique and Hexvix
    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

Primary outcome measures

  • Residual disease and/or upstaging [Time frame: 6 to 8 weeks from the intervention]
Secondary outcome measures (5)
  • Number of Participants diagnosed with malignant lesions [Time frame: 6 to 8 weeks from the intervention]
  • The European organization for reasearch and treatment of cancer quality of life questionnaire for patients with non-muscle invasive bladder cancern [Time frame: from date of randomization until 20 weeks from randomization]
  • EQ-5D-5L [Time frame: from date of randomization until 20 weeks from randomization]
  • EQ VAS [Time frame: from date of randomization until 20 weeks from randomization]
  • Adverse events [Time frame: from date of randomization until 20 weeks from randomization]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06548438 · CDS01FS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗