A Randomized, Comparative Phase III, 2-center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 2
- 主要终点
- Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.
研究概览
简要总结
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.
The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.
详细描述
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.
Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen is according to standard clinical practice in Denmark.
Recurrence of non-invasive bladder cancer is frequent, and this study is designed to investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard TURB
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
- •Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral resection of the bladder
- •Above 18 years
- •Written informed consent obtained
排除标准
- •Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
- •Patient with porphyria.
- •Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
- •Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
- •Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).
- •Conditions associated with a risk of poor protocol compliance.
研究组 & 干预措施
Hexvix cystoscopy group
干预措施: Hexvix (Drug)
White light
Standard White light cystoscopy
干预措施: Standard white light cystoscopy (Other)
结局指标
主要结局
Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.
时间窗: 1 year
To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.
次要结局
- Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy.(At day 0)
- False Positive Detection Rate Patient Level(12 months)