Trial Information
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.
Inclusion Criteria:
- Patients over 18 years of age.
- Patients of either sex.
- Patients with documented or highly suspected non-invasive bladder cancer.
Exclusion Criteria:
- 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
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
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.
Safety Issue:
No
Principal Investigator
Dr. Carlos Hernández
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gregorio Marañón Hospital, Madrid
Authority:
Spain: Spanish Agency of Medicines
Study ID:
GEH-HEX-2007-01
NCT ID:
NCT00634621
Start Date:
February 2008
Completion Date:
September 2010
Related Keywords:
- Bladder Cancer
- Bladder
- Cancer
- Cystoscopy
- Hexaminolevulinate
- Hexvix
- Urinary Bladder Neoplasms