Suspected non-muscle invasive (superficial) bladder cancer MedDRA version: 17.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Vidon
Product Code: PVP-Hypericin
Pharmaceutical Form: Powder for intravesical solution
CAS Number: 548-04-9
Current Sponsor code: SPH-3542
Other descriptive name: Hypericin
Concentratio
Sponsors
Sanochemia Pharmazeutika AG
Eligibility
Sex/Gender
All
Inclusion 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 cystoscopy that have to be diagnosed at the respective study site prior to Visit 1 4. Patients including multiple bladder 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. 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 165 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 inspecting the bladder under white light first, followed by blue light.;Secondary Objective: • Diagnostic performance regarding flat and papillary tumours • False-positive rate • To evaluate systemic absorption and pharmacokinetics (PK) of Hypericin after a single intravesical instillation of PVP-Hypericin in a sub-group of patients (N=15-20) • To assess the safety of PVP-Hypericin.;Primary end point(s): The percentage of patients in whom non-muscle invasive bladder cancer (Tis and / or TaT1) is detected by Hypericin cystoscopy (PVP-Hypericin instillation; white light followed by blue light) as confirmed by biopsy results.;Timepoint(s) of evaluation of this end point: after LVLS | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: after LVLS;Secondary end point(s): • The primary endpoint variable for Tis and TaT1 separately (on patient and lesion level) • False-positive rate • Systemic absorption and pharmacokinetics of Hypericin after a singledose intravesical PVP-Hypericin (sub-group analysis) • Frequency and severity of systemic and local adverse events (AE) | — |
Countries
Austria, Germany
Contacts
Public ContactClinical Department
Sanochemia Pharmazeutika AG
Outcome results
None listed