Transplant Optimization Using Functional Imaging (TROFI)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bronchiolitis Obliterans
- Sponsor
- FLUIDDA nv
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Airway Resistance (iRaw) using FRI
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Pregnant or lactating female
- •Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation
Outcomes
Primary Outcomes
Airway Resistance (iRaw) using FRI
Time Frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Specific Airway Volume (siVaw) using FRI
Time Frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Airway Volume (iVaw) using FRI
Time Frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Lobe Volumes (iVlobes) using FRI
Time Frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Air Trapping using FRI
Time Frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Specific Airway Resistance (siRaw) using FRI
Time Frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Blood Vessel Density or Fibrosis Score using FRI
Time Frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Airway Wall Thickness using FRI
Time Frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Internal Lobar Airflow Distribution using FRI
Time Frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Low attenuation or Emphysema Score using FRI
Time Frame: 12 months
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.