Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer
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The purpose of this study is to determine the effectiveness of hexaminolevulinate (Hexvix) in the diagnosis and treatment of patients with non-invasive bladder cancer and if it results in a change in patient management.
A Post-authorization, Observational Study to Assess the Impact of Blue Light Cystoscopy After Administration of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Each patient enrolled into the study will be infused with 50 mL of a 2 mg/mL Hexvix solution in the bladder using a catheter. Subsequently, after fluid retention by the patient in the bladder for one hour, the bladder will be emptied.
Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy. [ Time Frame: Day 0 (Post contrast administration) ]
Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®.
Secondary Outcome Measures :
Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level. [ Time Frame: Day 0 (Post contrast administration) ]
The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with documented or suspected bladder cancer.
Patients over 18 years of age.
Patients of either sex.
Patients with documented or highly suspected non-invasive bladder cancer.
Patients with hypersensitivity to the drug substance or any excipient of Hexvix.
Patients with porphyry.
Women of childbearing age.
Patients at a high risk of suffering extensive bladder inflammation e.g. patients after intravesical BCG treatment, patients with moderate or severe leukocyturia or patients undergoing recent bladder surgery.