Surefire Precision Infusion System Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 111
- 试验地点
- 10
- 主要终点
- Objective tumor response
研究概览
简要总结
This project involves the collection and analysis of retrospective and prospective data on patients diagnosed with hepatocellular carcinoma (HCC) in which the Surefire Precision Infusion System was used/will used be to deliver transarterial chemoembolization with doxorubicin-eluting beads (DEB-TACE). The purpose is to compare tumor and medical response in a real-world setting as well as identify potential areas for future clinical research.
详细描述
Conventional transarterial chemoembolization with lipiodol/doxorubicin (cTACE) is known to prolong survival compared to supportive therapy in certain patients with unresectable HCC, including patients with unilateral portal vein invasion (PVI). The best results for cTACE occur when the dose is delivered in a highly targeted manner into the tumor. Dense accumulation of embolic spheres or lipiodol into the tumor as documented by computed tomography (CT) has been shown to have improved outcomes. However, with standard endhole catheters, achieving maximum delivery of embolic agents is significantly limited by the development of stasis, non-target delivery and subsequent non-target injury. Thus, when this procedure is performed with endhole catheters, there is significant variability in the delivery of the agent that is entirely dependent on the flow pattern of the target tumor. Therefore, current techniques result in various degrees of embolization with variability in dosages and angiographic endpoints.
DEB-TACE is a relatively new modality associated with favorable systemic doxorubicin exposure/toxicity and liver-specific toxicity compared to cTACE. It is currently utilized for: (1) patients who have unresectable HCC; (2) patients who meet the Milan Criteria and are currently on liver transplantation lists; and (3) downstaging patients into Milan Criteria for possible liver transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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 who have undergone or will undergo DEB-TACE for HCC delivered by the Surefire® Precision Infusion System
- •Patients aged 18 years or older
- •Diagnosis of HCC
- •Has a discrete hepatic artery(s) feeding the vessel with diameter(s) of the vessels ≥ 1.5 mm
排除标准
- •Contraindications for doxorubicin administration
- •Vessels providing flow to the tumor that are < 1.5 mm in diameter(s)
- •Patients who are unable to provide informed consent
结局指标
主要结局
Objective tumor response
时间窗: 6 months following initial DEB-TACE procedure.
次要结局
- Objective tumor response(1 and 3 months following initial DEB-TACE procedure)
- Changes in alpha-fetoprotein (AFP) blood levels(1, 3 and 6 months following initial DEB-TACE procedure)
- Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s)(6 months following initial DEB-TACE procedure)
- Size of doxorubicin-eluting beads used during DEB-TACE procedure(s)(DEB-TACE procedure(s))
- Tumor characteristics(DEB-TACE procedure(s))
