Status:
COMPLETED
Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer
Lead Sponsor:
GE Healthcare
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Patients over 18 years of age.
- Patients of either sex.
- Patients with documented or highly suspected non-invasive bladder cancer.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT00634621
Start Date
February 1 2008
End Date
September 1 2010
Last Update
August 25 2014
Active Locations (1)
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1
GE Healthcare
Madrid, Spain, 28108