Overview

Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
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 patient management.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GE Healthcare
Treatments:
Aminolevulinic Acid
Criteria
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.