Hexvix Photodynamic Therapy in Patients With Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01303991
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : February 25, 2011
Karl Storz
Information provided by:

February 18, 2011
February 25, 2011
February 25, 2011
March 2005
August 2008   (Final data collection date for primary outcome measure)
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)

Same as current
No Changes Posted
The number of tumour-free patients after 6 months
To assess the efficacy of Hexvix PDT in patients with intermediate and high-risk bladder cancer
Same as current
Not Provided
Not Provided
Hexvix Photodynamic Therapy in Patients With Bladder Cancer
A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk 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.
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.
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Intermediate or High-risk Bladder Cancer
Other: Hexvix PDT with Karl Storz T-Light
Experimental: Hexvix PDT
Intervention: Other: Hexvix PDT with Karl Storz T-Light
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female aged 18 years or above who have given written informed consent.
  • Patients with intermediate or high-risk superficial bladder cancer, defined as low-grade early recurrence within 6 months after local chemotherapy or BCG, primary or recurrent high-grade disease (TaG3, TaG3 with CIS or CIS alone) or patients with primary T1G3 who are tumour free at second resection.

Exclusion Criteria:

  • Patients with muscle invasive tumour
  • Patients with bladder shrinkage
  • Patients who have received prior PDT for bladder cancer
  • History of T1G3 disease or other indications for cystectomy
  • Patient with porphyria
  • Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with PDT)
  • Patients who have received BCG or chemotherapy within three months prior to Hexvix instillation, except for a single dose of chemotherapy for prevention of seeding after resection
  • Known allergy to hexaminolevulinate or a similar compound
  • Participation in other clinical studies either concurrently or within the last 30 days
  • Women of child-bearing potential.
  • Conditions associated with a risk of poor protocol compliance
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
PC B251/03
Not Provided
Not Provided
Photocure ASA
Karl Storz
Principal Investigator: Dirk Zaak, MD Urology Department, Medizinische Fakultät der LMU Muenchen
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP