Clinical trial · Interventional
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix
NCT00785694CI-TRIAL-00017632withdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Rejected ethics approval in UK and Holland
Summary
Brief summary (as posted)
This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).
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 |
|---|---|---|---|
| hexaminolevulinate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- B
- description
- One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.
- interventionNames
- Drug: hexaminolevulinate
- type
- NO_INTERVENTION
- label
- A
- description
- Multiple instillations of mitomycin C after transurethral resection in white light alone.
Primary outcomes (1)
- measure
- Rate of bladder cancer recurrence
- timeFrame
- 12 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject is not of childbearing potential and signed informed consent. * Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy. Exclusion Criteria: * The subject was previously included in this study. * The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS). * The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence. * The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract. * The subject has gross haematuria. * The subject has a history of porphyria.
References
Publications (0)
Data not yet available
No reference posted for this study.