Interstitial Lung Disease
Conditions
Keywords
Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
Brief summary
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.
Detailed description
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.
Interventions
DEVICEChest CT
Inspiration and expiration chest CT
DIAGNOSTIC_TESTPulmonary Function Testing
Measure lung function
Sponsors
Henry M. Jackson Foundation for the Advancement of Military Medicine
University of Missouri-Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
All participants will undergo CT and pulmonary function testing.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects with ILD: Subjects must have a physician diagnosis of ILD and be in stable pulmonary condition at the time of the CT * Healthy subjects: Subjects must have no history of pulmonary disease and smoked less than 100 cigarettes in their lifetime
Exclusion criteria
* Subjects less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Motion as Assessed by CT | Study visit 1 of a single visit study | A computer algorithm will compare the inspiration and expiration CT scans to determine regional lung motion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung Motion: Lobar Strain Which is a Ratio | Study visit 1 of a single visit study | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Pulmonary Assessment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Lung Motion as Assessed by CT
A computer algorithm will compare the inspiration and expiration CT scans to determine regional lung motion.
Time frame: Study visit 1 of a single visit study
Population: A total of 9 IPF subjects and 13 control subject had CT scans that could be analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulmonary Assessment | Lung Motion as Assessed by CT | Lung Volume Inspiration, IPF | 4.07 Liters | Standard Deviation 0.98 |
| Pulmonary Assessment | Lung Motion as Assessed by CT | Lung Volume Inspiration, Control | 5.56 Liters | Standard Deviation 0.9 |
| Pulmonary Assessment | Lung Motion as Assessed by CT | Lung Volume Expiration, IPF | 1.82 Liters | Standard Deviation 0.3 |
| Pulmonary Assessment | Lung Motion as Assessed by CT | Lung Volume Expiration, Control | 2.46 Liters | Standard Deviation 0.56 |
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
Time frame: Study visit 1 of a single visit study
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulmonary Assessment | Lung Motion: Lobar Strain Which is a Ratio | IPF | 0.37 Ratio | Standard Deviation 0.15 |
| Pulmonary Assessment | Lung Motion: Lobar Strain Which is a Ratio | Control | 0.39 Ratio | Standard Deviation 0.3 |