Assessment of Lung Movement With Computed Tomography (CT)
Primary Purpose
Interstitial Lung Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chest CT
Pulmonary Function Testing
Sponsored by
About this trial
This is an interventional basic science trial for Interstitial Lung Disease focused on measuring Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
Eligibility Criteria
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
Sites / Locations
- University of Missouri-Columbia
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pulmonary Assessment
Arm Description
All participants will undergo a Chest CT scan and pulmonary function testing
Outcomes
Primary Outcome Measures
Lung Motion as Assessed by CT
A computer algorithm will compare the inspiration and expiration CT scans to determine regional lung motion.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03068091
First Posted
February 25, 2017
Last Updated
April 22, 2020
Sponsor
University of Missouri-Columbia
Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03068091
Brief Title
Assessment of Lung Movement With Computed Tomography (CT)
Official Title
Assessment of Lung Movement With CT in Healthy Subjects and Patients With ILD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will undergo CT and pulmonary function testing.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Assessment
Arm Type
Other
Arm Description
All participants will undergo a Chest CT scan and pulmonary function testing
Intervention Type
Device
Intervention Name(s)
Chest CT
Intervention Description
Inspiration and expiration chest CT
Intervention Type
Diagnostic Test
Intervention Name(s)
Pulmonary Function Testing
Intervention Description
Measure lung function
Primary Outcome Measure Information:
Title
Lung Motion as Assessed by CT
Description
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
Secondary Outcome Measure Information:
Title
Lung Motion: Lobar Strain Which is a Ratio
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talissa Altes, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared with the sponsor
Learn more about this trial
Assessment of Lung Movement With Computed Tomography (CT)
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