Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy(Hypericin PDD)
- Conditions
- C67Malignant neoplasm of bladder
- Registration Number
- DRKS00003324
- Lead Sponsor
- Sanochemia Pharmazeutika AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 227
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)
8. All women of child-bearing potential must have a negative serum or
urine pregnancy test at screening and must use hormonal contraception
or intrauterine device (IUD) during the treatment and for at least one
month thereafter.
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
6. Macroscopic hematuria
7. Bladder stones
8. Bladder capacity = 50 mL
9. Administration of any other photosensitiser < 6 months
10. Oral intake of any drug or substance containing Hypericum extract,
Hypericin, Pseudohypericin or parts of Hypericum plants (capsules,
tablets, powder, drops, teas, etc.) within 14 days prior to PDD, during the study and until
Visit 4 for patients included in the PK subgroup
11. All anticoagulation therapy except low dose heparin and aspirin
12. Known allergy to Hypericin, polyvinylpyrrolidone (PVP, povidone) or
any similar compounds
13. Pregnant or breast-feeding women
14. Participation in other clinical studies with investigational drugs
either concurrently or within the last 30 days
15. Previous participation in this clinical study
16. Conditions associated with a risk of poor protocol compliance
17. Patients with mental health problems
18. Patients who have difficulties in understanding the language in
which the patient information is given
19. Legal incapacity and/or other circumstances rendering the patient
unable to understand the nature, scope and possible impact of the study
20. Patients in custody by juridical or official order
21. Staff of the study centre, staff of the sponsor or CRO, the
investigator him-/herself or close relatives of the investigator
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To collect preliminary data on the diagnostic performance of Hypericin-guided cystoscopy regarding the detection of non-muscle invasive bladder cancer . Standard, white light cystoscopy will be compared with Hypericin assisted cystoscopy (PVP-Hypericin instillation; white light followed by blue light (Hypericin PDD)) using a within-patient design by<br>inspecting the bladder under white light first, followed by blue light. Diagnostic performance is confirmed by biopsy.
- Secondary Outcome Measures
Name Time Method • Diagnostic performance regarding flat and papillary tumours<br>• False-positive rate<br>• To evaluate systemic absorption and pharmacokinetics (PK) of<br>Hypericin after a single intravesical instillation of PVP-Hypericin in a<br>sub-group of patients (N=15-20)<br>• To assess the safety of PVP-Hypericin (data collection of adverse events)