Evaluation of the benefits and effects of hypericin Photodynamic therapy (PDT) in the clinical treatment of superficial bladder carcinoma.
- Conditions
- the study population consists of 10 patients with anatomopathologically proven muscle invasive TCC without metastasis. These patients require a cystoscopy. Before the planned cystoscopy, the bladders will be emptied and a 9µM PVP-hypericin solution will be instilled for 2 hours. Next, the bladder will be irradiated. 30 minutes to 1hour after irradiation, the bladder will be removed and investigated on residual tumor, tumor necrosis and affected normal urothelium.MedDRA version: 9.1Level: LLTClassification code 10034942Term: Photodynamic therapy
- Registration Number
- EUCTR2007-001302-25-BE
- Lead Sponsor
- ab for pharmaceutical biology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
* Bladder tumor which requires cystectomy
* Anatomopathologically proven TCC
* No distant metastasis
* General condition of the patient is good enough for cystectomy
* life expectancy is at least 1 year
* TUR at least 6 weeks before cystectomy
* Signed informed consent
* instillation fluid needs to be retained in the bladder for 5 hours
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
* Distant metastatsis
* Life expectancy less than 1 year
* TUR less than 6 weeks before planned cystectomy
* Poor general condition whereby the patient can't undergo cystectomy
* Evacuation of the instillatin fluid if it is retained less than 2 hours in the bladder
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method