Clinical trial · Interventional
A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
A Randomized, Comparative Phase III, 2-center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
NCT00412971CI-TRIAL-00012369completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer. The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hexvix | Drug | — | UNRESOLVED |
| Standard white light cystoscopy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Hexvix cystoscopy group
- interventionNames
- Drug: Hexvix
- type
- OTHER
- label
- White light
- description
- Standard White light cystoscopy
- interventionNames
- Other: Standard white light cystoscopy
Primary outcomes (1)
- measure
- Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.
- timeFrame
- 1 year
- description
- To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral resection of the bladder * Above 18 years * Written informed consent obtained Exclusion Criteria: * Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy). * Patient with porphyria. * Known allergy to hexyl aminolevulinate hydrochloride or a similar compound. * Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days. * Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter). * Conditions associated with a risk of poor protocol compliance.
References
Publications (1)
- DERIVEDHermann GG, Mogensen K, Carlsson S, Marcussen N, Duun S. Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in Ta/T1 patients: a randomized two-centre study. BJU Int. 2011 Oct;108(8 Pt 2):E297-303. doi: 10.1111/j.1464-410X.2011.10090.x. Epub 2011 Mar 17. PMID 21414125