A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate based photodynamic therapy in patients with intermediate or high-risk transitional cell carcinoma of the bladder.
详细描述
Non-muscle invasive bladder cancer is currently treated by transurethral resection (TURB) and/or fulguration. However, recurrence and progression rates following endoscopic treatment of visible lesions are significant. To prevent recurrent and progressive disease, adjuvant intravesical chemotherapy and immunotherapy are applied. There is also increasing interest in new therapeutic strategies such as photodynamic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Male or female aged 18 years or above who have given written informed consent.
- •Patients with intermediate or high-risk superficial bladder cancer, defined as low-grade early recurrence within 6 months after local chemotherapy or BCG, primary or recurrent high-grade disease (TaG3, TaG3 with CIS or CIS alone) or patients with primary T1G3 who are tumour free at second resection.
排除标准
- •Patients with muscle invasive tumour
- •Patients with bladder shrinkage
- •Patients who have received prior PDT for bladder cancer
- •History of T1G3 disease or other indications for cystectomy
- •Patient with porphyria
- •Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with PDT)
- •Patients who have received BCG or chemotherapy within three months prior to Hexvix instillation, except for a single dose of chemotherapy for prevention of seeding after resection
- •Known allergy to hexaminolevulinate or a similar compound
- •Participation in other clinical studies either concurrently or within the last 30 days
- •Women of child-bearing potential.
- •Conditions associated with a risk of poor protocol compliance
结局指标
主要结局
Number of patients with adverse events
To assess the safety of photodynamic therapy (PDT) using Hexvix and the Karl Storz T-light PDT System in patients with recurrent bladder cancer. (assessment of adverse events, blood biochemistry, vital signs, urodynamics)
次要结局
- The number of tumour-free patients after 6 months