Hexvix Photodynamic Therapy in Patients With Bladder Cancer
The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate based photodynamic therapy in patients with intermediate or high-risk transitional cell carcinoma of the bladder.
Intermediate or High-risk Bladder Cancer
Other: Hexvix PDT with Karl Storz T-Light
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer|
- Number of patients with adverse events [ Designated as safety issue: Yes ]
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)
- The number of tumour-free patients after 6 months [ Designated as safety issue: No ]To assess the efficacy of Hexvix PDT in patients with intermediate and high-risk bladder cancer
|Study Start Date:||March 2005|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303991
|Principal Investigator:||Dirk Zaak, MD||Urology Department, Medizinische Fakultät der LMU Muenchen|