NCT06548438RecruitingPhase 4
The impact of PDD during TURB for NMIBC: a prospective randomized controlled trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Primary objective is to 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 29 Jan 2025
- Start date
- 22 Oct 2025
- Lead sponsor
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Diseases
- Bladder cancer
- NCT number
- NCT06548438
- EU CT number
- 2024-514316-27-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 300
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with visible incomplete resection during primary TURB.
- Previous diagnosis of porphyria.
Other illness
- Patients with history of recurrent NMIBC
- Patients with metastatic disease or with a preoperative CT scan highly suspected for MIBC.
- Allergy to hexaminolevulinate hydrochloride or any of the ingredients listed in Smpc of the product.
- Diagnosis of bladder inflammation, a recent urinary tract infection.
Other
- Diagnosis of from gross haematuria or blood in the urine.
- Pregnancy and breastfeeding
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.