Open Prospective Within Patient, Phase IIa Study of Hexvix Flexible Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer After 30 Minutes Instillation of Hexvix in Patients With Known or Suspicion of Bladder Cancer
This study is an open, prospective, within patient, controlled, multi-center, Phase IIa
study in patients with bladder cancer.
The bladder of all patients will be instilled with 50 mL Hexvix® 8 mM solution and evacuated
after 30 minutes. After bladder evacuation, the bladder will be examined under white light
cystoscopy using the Karl Storz flexible videocystoscope. Tumors visible under white light
will be mapped. Then the bladder is evaluated with blue light and lesions seen by blue light
will be mapped. Biopsies of all visible tumors will be taken using both white and blue light
prior to resection of all lesions.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Number of lesions
An average of 15 min (during cystoscopy)
Alexander Karl, MD
Department of Urology, LMU Munich, Germany
Germany: Federal Institute for Drugs and Medical Devices