A Feasibility Study to Determine an Adequate Dose of ICG for the Liver Function Assessment System in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 主要终点
- ICG dye detection using the LFT system compared to serial blood sampling ethods.
研究概览
简要总结
The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an adequate dose based on LFA technology and 3) determine an adequate time period for LFA determination.
详细描述
Four cohorts of subjects will be enrolled. The fist two cohorts will receive fixed doses of ICG dye (2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg) followed by 20 minutes of LFT monitoring. The final two cohorts will receive weight based doses of ICG dye (0.1 mg/kg, 0.5 mg/kg) followed by 20 minutes of LFT monitoring. Additionally the final two cohorts will have serial blood draws before the ICG dose and at 5, 10, 15 and 20 minutes post ICG dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects, aged 18 to 75 years, inclusive
- •Informed consent documentation understood and signed.
排除标准
- •Known allergy or sensitivity to the ICG or to iodide contrast dye
- •Pregnant women or those nursing babies
研究组 & 干预措施
Liver Funtion Test Dye Detection Monitor
All cohorts receive continuous LFT monitoring post ICG injection.
干预措施: ICG Dye (Drug)
Serial Blood Draws
Cohorts 3 and 4 - weight based doses of ICG dye followed by serial blood draws at 5, 10, 15 and 20 minutes post ICG injection.
干预措施: ICG Dye (Drug)
结局指标
主要结局
ICG dye detection using the LFT system compared to serial blood sampling ethods.
时间窗: 20 minutes post ICG dose
Determination of an adequate dose for the Cardiox Liver Functioning Assessment LFA system to produce liver function assessments consistent with serial blood sampling methods.
次要结局
- Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time.(20 minutes post ICG dose)
- ICG fluorescence detection at the scaphoid fossa of the ears(20 minutes post ICG dose)