Prospective Study for 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 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.

Official Title
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Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

Conditions
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Bronchiolitis Obliterans, Lung Transplant Rejection

Intervention / Treatment
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* Radiation: HRCT 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 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 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>High Resolution Computed Tomography scans will be taken | Radiation: HRCT scans<br>* A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 2, visit 3, visit 4, visit 5, visit 6, and visit 7. An upper airway (UA) scan will be taken on visit 2.<br>* Other names: High Resolution Computed Tomography scans;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Airway Volume (iVaw) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. | 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant | 
| Change in Airway Resistance (iRaw) using FRI | 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. | 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant | 
| Change in Specific Airway Volume (siVaw) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. | 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant | 
| Change in Specific Airway Resistance (siRaw) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. | 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant | 
| Change in Lobe Volumes (iVlobes) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. | 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant | 
| Change in Air trapping using FRI | 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. | 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant | 
| Change in Internal Lobar Airflow Distribution using FRI | 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). | 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant | 
| Change in Low Attenuation or Emphysema Score using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. | 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant | 
| Change in Blood Vessel Density or Fibrosis Score using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. | 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant | 
| Change in Airway Wall Thickness using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. | 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant | 

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