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the lung transplantation program at the site is on hold
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRCT scans | Experimental | High Resolution Computed Tomography scans will be taken |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRCT scans | Radiation | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried De Backer, M.D., M.S. | University Hospital of Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Edegem | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D001989 | Bronchiolitis Obliterans |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| 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 |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D000092124 | Organizing Pneumonia |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |