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临床试验/NCT02967523
NCT02967523终止不适用

Surefire Precision Infusion System Registry

Surefire Medical, Inc.10 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2016年5月最近更新:
适应症

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))

研究者

发起方
Surefire Medical, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (10)

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