Transplant Optimization Using Functional Imaging (TROFI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Airway Resistance (iRaw) using FRI
研究概览
简要总结
The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust and automated segmentation algorithms will be developed for these parameters, focusing on quantitative computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics tool. The evolution of BOS over time will be monitored using nmon-rigid image registration methods.
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
- •Male or female patient ≥ 18 years old
- •Written informed consent obtained
- •Patient who had undergone a lung transplant a year ago or more
- •Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before screening visit and will continue to use a contraception method during the study
- •The patient must be able to perform the lung monitoring at home
- •Patients diagnosed with BOS 0, BOS 0-p or BOS 1
排除标准
- •Pregnant or lactating female
- •Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation
结局指标
主要结局
Airway Resistance (iRaw) using FRI
时间窗: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Specific Airway Volume (siVaw) using FRI
时间窗: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Airway Volume (iVaw) using FRI
时间窗: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Lobe Volumes (iVlobes) using FRI
时间窗: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Air Trapping using FRI
时间窗: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Specific Airway Resistance (siRaw) using FRI
时间窗: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Blood Vessel Density or Fibrosis Score using FRI
时间窗: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Airway Wall Thickness using FRI
时间窗: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Internal Lobar Airflow Distribution using FRI
时间窗: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Low attenuation or Emphysema Score using FRI
时间窗: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
次要结局
未报告次要终点