At a glance
ClinicalIndex Comparison Record- ✓Suspicious or confirmed bladder cancer diagnosis
- ✓Age 18 years or older
- ✕Gross hematuria that may impair visualization (light hematuria allowed if manageable)
- ✕BCG immunotherapy or intravesical chemotherapy within past 6 weeks
- ✕History of porphyria
- ✕Known allergy to hexaminolevulinate hydrochloride or similar compounds
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Comparative Within Patient Controlled, Multi-center Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer
In Brief
A Phase 3 clinical trial evaluating Hexaminolevulinate Hydrochloride and Richard Wolf Photodynamic Diagnostic Equipment (PDD) system for Bladder Cancer. Completed, enrolled 158 participants across 7 sites.
Detailed Summary
A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.
Study Details
Timeline
Interventions
Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.
Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.