Clinical trial · Interventional
The Impact of PDD During TURB for NMIBC
The Impact of PDD During TURB for NMIBC: a Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transurethral resection of the bladder performed with PDD tecnique and Hexvix | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Photodynamic diagnosis using Hexvix
- description
- Transurethral resection of the bladder (TURB) is performed using photodynamic diagnosis (PDD) which involves the of use the study drug (Hexvix) to allow for better visualisation and subsequent resection
- interventionNames
- Procedure: Transurethral resection of the bladder performed with PDD tecnique and Hexvix
- type
- NO_INTERVENTION
- label
- White light
- description
- Transurethral resection of the bladder (TURB) is performed using the standard white light procedure
Primary outcomes (1)
- measure
- Residual disease and/or upstaging
- timeFrame
- 6 to 8 weeks from the intervention
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available