DRKS00003324
Completed
Phase 2
Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy(Hypericin PDD)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- C67
- Sponsor
- Sanochemia Pharmazeutika AG
- Enrollment
- 227
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who have given their signed declaration of consent and data
- •protection declaration
- •2\. Males and females aged \= 18 years
- •3\. Patients scheduled for transurethral resection of the bladder of a suspected bladder
- •cancer based on recent findings in cystoscpy that have to be diagnosed at the respective study site prior to Visit 1
- •4\. Patients including multiple baldder tumours or suspicious lesions
- •5\. Patients with initial and/or recurrent bladder cancer
- •6\. Patients with adequate renal and hepatic function according to the
- •investigator
- •7\. No known anaesthetic risks (risk of narcosis ASA 1\-3\)
Exclusion Criteria
- •1\. Intravesical BCG (Bacillus Calmette\-Guérin) instillation \= 6 months
- •2\. Intravesical Mitomycin instillation \= 3 months
- •3\. Patients at high risk of suffering extensive bladder inflammation
- •4\. Recent bladder surgery (resection) \= 3 months
- •5\. Patients with symptoms and signs of urinary tract infection, e.g.
- •moderate or severe leukocyturia, dysuria, alguria, urgency, frequency,
- •polyuria, offensive urine, cloudy urine, significant bacteriuria (\= 100000
- •CFU/mL), positive urine culture, asymptomatic bacteriuria, suprapubic
- •tenderness, pain or pressure, flank or back pain, fever \= 38°C,
- •costovertebral angle tenderness
Outcomes
Primary Outcomes
Not specified
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