NCT04574401已完成1 期
A Phase 1 Safety and Efficacy Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This is a Phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is between the ages of 18 and
- •Subject has a confirmed adenocarcinoma by histology of the prostate.
- •Subject has CAPRA > 6, or T3 a or b disease on imaging (TRUS and/or MRI), or regional lymphadenopathy suspicious for nodal metastases
- •Subject is scheduled to undergo robotic prostatectomy with extended pelvic lymph node dissection (ePLND) using an da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.
- •Subject is willing and able to provide informed consent
- •Subject is considered capable of complying with study procedures and of understanding a written informed consent document.
- •Subject must be treatment naïve (not having received neo-adjuvant therapy, radiation therapy, hormonal therapy, androgen deprivation therapy within the last 4 months excluding Finasteride, Dutasteride, or other 5 alpha reductase inhibitors, or focal ablation techniques)
排除标准
- •Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Subject is currently participating in and receiving study therapy or has participated in a study of an investigational agent within the past 6 months; is receiving study therapy or is involved in a significant risk investigational device study within the past 6 months
- •Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
- •Subject has a known history of bone metastasis documented on the basis of bone scans and/or biopsy
- •Subject has a known history of acute or chronic liver or kidney disease
研究组 & 干预措施
Dose escalation
Experimental
Dose-cohort escalation of a single intravenous injection of IS-002 at four different dose levels
干预措施: IS-002 (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
时间窗: 14 days
Number of participants treated with IS-002 with treatment-emergent adverse events as assessed by CTCAE v5.0
次要结局
- IS-002 Clearance (CL)(-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours)
- IS-002 Maximum Plasma Concentration (Cmax)(-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours)
- IS-002 Half-Life (t½)(-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours)
- IS-002 Area Under the Plasma Concentration Versus Time Curve (AUC)(-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours)
研究者
研究点 (1)
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