Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- adverse events
研究概览
简要总结
The primary purpose of this study is to demonstrate the safety and effectiveness of using an intra-operative ultrasound contrast agent(Definity®) for the identification of known liver tumors.
详细描述
The primary objective of this study is to demonstrate the safety of the use of intra-operative ultrasound contrast (Definity®) administration. The secondary objective of this study is to demonstrate the improved image quality and conspicuity of known liver tumors using contrast enhancement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Undergoing a hepatic resection or hepatic ablation of pre-operative visualized liver tumor:
- •≥ 18 years of age
- •If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery
- •If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits.
- •IRB-approved informed consent, signed by the subject or the subject's legally authorized representative. ≥ 18 years of age
排除标准
- •Not a suitable candidate for operation
研究组 & 干预措施
Definity Contrast Dye
During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors
干预措施: Definity® (Drug)
结局指标
主要结局
adverse events
时间窗: 6-weeks post surgery
identification of liver tumors
时间窗: intra-operative
次要结局
- improved ablation of liver tumors(6-weeks post surgery)
研究者
Robert C. Martin
MD
University of Louisville