A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer
Non-muscle invasive bladder cancer is currently treated by transurethral resection (TURB)
and/or fulguration. However, recurrence and progression rates following endoscopic treatment
of visible lesions are significant. To prevent recurrent and progressive disease, adjuvant
intravesical chemotherapy and immunotherapy are applied. There is also increasing interest
in new therapeutic strategies such as photodynamic therapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with adverse events
To assess the safety of photodynamic therapy (PDT) using Hexvix and the Karl Storz T-light PDT System in patients with recurrent bladder cancer. (assessment of adverse events, blood biochemistry, vital signs, urodynamics)
Yes
Dirk Zaak, MD
Principal Investigator
Urology Department, Medizinische Fakultät der LMU Muenchen
Germany: Federal Institute for Drugs and Medical Devices
PC B251/03
NCT01303991
March 2005
August 2008
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