EUCTR2011-001819-30-DE进行中（未招募）不适用
Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy (Hypericin PDD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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