Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Residual disease burden
研究概览
简要总结
Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.
详细描述
Objectives are as follows:
Primary i) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among patients with a high-grade tumor at time of resection ii) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among all evaluable study participants.
Secondary i) Among all evaluable study participants: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.
ii) Among patients undergoing intravesical induction: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 undergoing TURBT for radiographic or cystoscopic positive tumor
- •18+ years old
- •Upper tract evaluated using standard of care throughout duration of the study
- •Induction intravesical therapy initiated within four weeks of TURBT
排除标准
- •Variant histology consisting of less than 50% urothelial carcinoma
- •History, or current diagnosis, of upper tract tumor or muscle-invasive bladder cancer
- •Prior history of pelvic radiation
- •Active urinary tract infection (UTI)
- •Patients who are noncompliant with the study protocol
研究组 & 干预措施
Blue light Cystoscopy
Patients with bladder tumors will undergo BLC TURBT
干预措施: Cysview (Drug)
Blue light Cystoscopy
Patients with bladder tumors will undergo BLC TURBT
干预措施: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system (Device)
White light Cystoscopy
Patients with bladder tumors will undergo WLC TURBT
干预措施: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system (Device)
结局指标
主要结局
Residual disease burden
时间窗: Up to 24 months
The residual tumor burden will be assessed by the standard of care testing, such as cystoscopy and cytology at 3 month intervals.
Minimal residual disease burden
时间窗: Up to 24 months
Minimal residual disease (MRD) in urine will be measured utilizing the Convergent's UroAmp test at 3 month intervals.
次要结局
- Recurrence-free survival(24 months)