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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 non-rigid image registration methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRCT scans | Experimental | HRCT scan will be taken |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Resolution Computed Tomography scan | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Airway Volume (iVaw) | Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5. | 12 months |
| Airway Resistance (iRaw) | Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5. | 12 months |
| Specific Airway Volume (siVaw) | Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5. | 12 months |
| Specific Airway Resistance (siRaw) | Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5. | 12 months |
| Lobe volumes (iVlobes) | Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5. | 12 months |
| Air trapping | Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5. | 12 months |
| Internal Lobar Airflow Distribution | Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5. | 12 months |
| Low Attenuation or Emphysema Score | Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Lederer, M.D., M.S. | Columbia University | Principal Investigator |
| James Lee, M.D., M.S. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States | ||
| Hospital of the University of Pennsylvania |
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| ID | Term |
|---|---|
| D001989 | Bronchiolitis Obliterans |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| 12 months |
| Blood Vessel Density or Fibrosis Score | Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5. | 12 months |
| Airway Wall Thickness | Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5. | 12 months |
| Gibson |
| Pennsylvania |
| 19104 |
| United States |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |