EUCTR2011-001819-30-AT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
相似试验
进行中（未招募）
不适用
Detection of bladder cancer using a fluorescent dye (PVP-Hypericin)Suspected non-muscle invasive (superficial) bladder cancerMedDRA version: 17.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001819-30-DESanochemia Pharmazeutika AG220
已完成
2 期
Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy(Hypericin PDD)C67Malignant neoplasm of bladderDRKS00003324Sanochemia Pharmazeutika AG227
已完成
3 期
The IMAGE1 S* Non-Muscle-Invasive bladder cancer study: A multicenter international randomized controlled study to compare the outcome using the IMAGE1 S* System versus White Light Imaging (WLI) during TURB of Non-Muscle-Invasive Bladder Cancer (NMIBC).bladder cancerNL-OMON47283Academisch Medisch Centrum100
已完成
不适用
Identification of muscle-invasive bladder cancer patients who will not benefit from neoadjuvant chemotherapy using circulating tumor cells.muscle invasive bladder cancermuscle invasive bladder carcinoma1003836410004994NL-OMON45144Erasmus MC, Universitair Medisch Centrum Rotterdam320
已完成
不适用
Urine-based Detection of Non-muscle Invasive BladderBladder CancerNCT03962933Nessn Azawi196