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

General Electric (GE)

Status: Completed

Conditions: Bladder Cancer

Treatments: Drug: Hexaminolevulinate (Hexvix)

Study type: Observational

Funder types: Industry

Identifiers

NCT00634621

GEH-HEX-2007-01

Details and patient eligibility

About

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.

Enrollment: 283 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.