Transplant Optimization Using Functional Imaging (TROFI)

Study Overview
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Brief Summary
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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.

Official Title
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Transplant Optimization Using Functional Imaging (TROFI)

Conditions
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Bronchiolitis Obliterans, Lung Transplant Rejection

Intervention / Treatment
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* Radiation: High Resolution Computed Tomography scans


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRCT scans<br>HRCT scan will be taken | Radiation: High Resolution Computed Tomography scans<br>* A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, visit 2, visit 3, visit 4 and visit 5. An Upper Airway (UA) scan will be taken on visit 1.<br>* Other names: HRCT scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway Volume (iVaw) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | 
| Airway Resistance (iRaw) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | 
| Specific Airway Volume (siVaw) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | 
| Specific Airway Resistance (siRaw) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | 
| Lobe Volumes (iVlobes) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | 
| Air Trapping using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | 
| Internal Lobar Airflow Distribution using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | 
| Low attenuation or Emphysema Score using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | 
| Blood Vessel Density or Fibrosis Score using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | 
| Airway Wall Thickness using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRCT, High Resolution Computed Tomography scans, Functional Respiratory Imaging, FRI, Computed Tomography, CT, Bronchiolitis Obliterans Syndrome, BOS, Lung Transplant