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.
- 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.
Type of Study:
Observational Model: Case-Only, Time Perspective: Prospective
The primary objective of this study is to quantify the increase in sensitivity for detection of non-invasive bladder cancer with blue light fluorescence cystoscopy using hexaminolevulinate (Hexvix) as compared to standard white light cystoscopy.
Outcome Time Frame:
Since cystoscopy until pathology results are available.
Dr. Carlos Hernández
Gregorio Marañón Hospital, Madrid
Spain: Spanish Agency of Medicines
- Bladder Cancer
- Urinary Bladder Neoplasms