NCT00785694撤回4 期
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of bladder cancer recurrence
研究概览
简要总结
This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is not of childbearing potential and signed informed consent.
- •Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.
排除标准
- •The subject was previously included in this study.
- •The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).
- •The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence.
- •The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.
- •The subject has gross haematuria.
- •The subject has a history of porphyria.
研究组 & 干预措施
B
Experimental
One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.
干预措施: hexaminolevulinate (Drug)
结局指标
主要结局
Rate of bladder cancer recurrence
时间窗: 12 Months
次要结局
未报告次要终点
研究者
研究点 (1)
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