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Brief Title: Detection of Bladder Tumors After 30 Min Instillation of Hexvix
Official Title: 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
Study ID: NCT01551407
Brief Summary: The objective of the study is to compare Hexvix® flexible cystoscopy and white light flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined as dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
LMU Munich, Munich, , Germany
Name: Alexander Karl, MD
Affiliation: Department of Urology, LMU Munich, Germany
Role: PRINCIPAL_INVESTIGATOR