Bladder Cancer
Conditions
Keywords
TURB, re-TURB, photodynamic diagnosis-PDD, Hexvix
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 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
PROCEDURETransurethral 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 and subsequent resection.
Sponsors
Photocure
A.O.U. Città della Salute e della Scienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual disease and/or upstaging | 6 to 8 weeks from the intervention | Compare the completeness of TURB with PDD vs TURB with WL in terms of proportion of patients with residual disease and/or upstaging at re-TURB |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants diagnosed with malignant lesions | 6 to 8 weeks from the intervention | Compare the detection of malignant lesions between PDD and WLC using high-definition (HD) equipment during both primary TURB and re-TURB |
| The European organization for reasearch and treatment of cancer quality of life questionnaire for patients with non-muscle invasive bladder cancern | from date of randomization until 20 weeks from randomization | The scale range from 24 (better outcome) to 96 (worse outcome) |
| EQ-5D-5L | from date of randomization until 20 weeks from randomization | The scale range from 5 (better outcome) to 25 (worse outcome) |
| EQ VAS | from date of randomization until 20 weeks from randomization | A self-rating question of overall health status, measured on a 0 (worse outcome) to 100 (better outcome) visual analogue scale |
| Adverse events | from date of randomization until 20 weeks from randomization | Assess treatment changes and adverse events associated with each technique |
Contacts
Primary ContactFrancesco Soria
Backup ContactLisa Giacometti
Outcome results
None listed