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®.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
38
50 ml Hexvix liquid instilled once into the bladder for 30 minutes prior to cystoscopy
LMU Munich
Munich, Munich, Germany
Number of lesions
Time frame: An average of 15 min (during cystoscopy)
Drug related adverse events
Time frame: From time of drug instillation until 24 hours after cystoscopy
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