Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Specific Airway Volume (siVaw) using FRI
研究概览
简要总结
The objective of this study is to detect BOS in an early stage by 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 rejection over time will be monitored using non-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
- •Patients who are planned to receive a lung transplant in the near future
- •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
排除标准
- •Pregnant or lactating female
- •Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation
研究组 & 干预措施
HRCT scans
High Resolution Computed Tomography scans will be taken
干预措施: HRCT scans (Radiation)
结局指标
主要结局
Change in Specific Airway Volume (siVaw) using FRI
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Lobe Volumes (iVlobes) using FRI
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Low Attenuation or Emphysema Score using FRI
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Airway Volume (iVaw) using FRI
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Airway Resistance (iRaw) using FRI
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airway resistance is defined as the pressure drop over the airways divided by the airflow.
Change in Specific Airway Resistance (siRaw) using FRI
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Air trapping using FRI
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Air trapping is defined as the regions in the lung with a gray value on the CT-scan image smaller than -850 HU at functional residual capacity.
Change in Internal Lobar Airflow Distribution using FRI
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airflow distribution is defined in as the percentage of air going to every lobe when inhaling from FRC to TLC and is calculated for every lobe as: IALDlobe \[%\] = 100 (VTLC_lobe - VFRC_lobe) / (VTLC_lungs - VFRC_lungs).
Change in Blood Vessel Density or Fibrosis Score using FRI
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Airway Wall Thickness using FRI
时间窗: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
次要结局
未报告次要终点