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| Name | Class |
|---|---|
| Henry M. Jackson Foundation for the Advancement of Military Medicine | OTHER |
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The purpose of this study is to determine whether patient with ILD have altered lung compliance on chest CT before they have macroscopic structural changes on CT.
Interstitial lung disease (ILD) is a group of lung disorders in which the lung tissues become inflamed and then damaged. Idiopathic Pulmonary Fibrosis (IPF) is one of the subtypes of ILD which has characteristic histological and CT features. It is well known that microscopic fibrosis occurs in the lungs of IPF patients well before the structural changes of fibrosis become apparent on CT. By combining sophisticated image analysis with CT scans obtained at full inspiration and full expiration, it may be possible to detect earlier changes of IPF than currently possible by looking at macro structural features alone. With the recent development of new therapeutics for IPF, early detection of the disease and improved monitoring of treatment efficacy will become important. Using CT to assess regional lung compliance has the potential to become an easily translated clinical tool.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Assessment | Other | All participants will undergo a Chest CT scan and pulmonary function testing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest CT | Device | Inspiration and expiration chest CT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Motion as Assessed by CT | A computer algorithm will compare the inspiration and expiration CT scans to determine regional lung motion. | Study visit 1 of a single visit study |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Motion: Lobar Strain Which is a Ratio | Lobar strain (S): the volumetric strain of each lobe i [i = Right Upper (RU), Right Lower (RL), Left Lower (LL), and Left Upper (LU)] as the difference in lobe volume between the expanded and contracted states, normalized by the lobe volume in the expanded state | Study visit 1 of a single visit study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Talissa Altes, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia | Columbia | Missouri | 65212 | United States |
De-identified data will be shared with the sponsor
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulmonary Assessment | All participants will undergo a Chest CT scan and pulmonary function testing Chest CT: Inspiration and expiration chest CT Pulmonary Function Testing: Measure lung function |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulmonary Assessment | All participants will undergo a Chest CT scan and pulmonary function testing Chest CT: Inspiration and expiration chest CT Pulmonary Function Testing: Measure lung function |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lung Motion as Assessed by CT | A computer algorithm will compare the inspiration and expiration CT scans to determine regional lung motion. | A total of 9 IPF subjects and 13 control subject had CT scans that could be analyzed. | Posted | Mean | Standard Deviation | Liters | Study visit 1 of a single visit study |
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This study had a single study visit. Adverse event data was collected at that visit. No follow-up of subjects was performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pulmonary Assessment | All participants will undergo a Chest CT scan and pulmonary function testing Chest CT: Inspiration and expiration chest CT Pulmonary Function Testing: Measure lung function |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Talissa Altes | University of Missouri | 573 882 1026 | ALTEST@HEALTH.MISSOURI.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2017 | Mar 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011658 | Pulmonary Fibrosis |
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| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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All participants will undergo CT and pulmonary function testing.
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| Pulmonary Function Testing |
| Diagnostic Test |
Measure lung function |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Lung Motion: Lobar Strain Which is a Ratio | Lobar strain (S): the volumetric strain of each lobe i [i = Right Upper (RU), Right Lower (RL), Left Lower (LL), and Left Upper (LU)] as the difference in lobe volume between the expanded and contracted states, normalized by the lobe volume in the expanded state | 9 idiopathic pulmonary fibrosis (IPF) and 13 control subjects (N=22) had CT's that were able to be analyzed for lobar strain (lung motion). | Posted | Mean | Standard Deviation | Ratio | Study visit 1 of a single visit study |
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| 24 |
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| 24 |
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