Detection of bladder cancer using a fluorescent dye (PVP-Hypericin)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

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

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