- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03068091
Assessment of Lung Movement With Computed Tomography (CT)
April 22, 2020 updated by: Talissa Altes, MD, University of Missouri-Columbia
Assessment of Lung Movement With CT in Healthy Subjects and Patients With ILD
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- University of Missouri-Columbia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Pulmonary Assessment
All participants will undergo a Chest CT scan and pulmonary function testing
|
Inspiration and expiration chest CT
Measure lung function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung Motion as Assessed by CT
Time Frame: Study visit 1 of a single visit study
|
A computer algorithm will compare the inspiration and expiration CT scans to determine regional lung motion.
|
Study visit 1 of a single visit study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung Motion: Lobar Strain Which is a Ratio
Time Frame: 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
|
Study visit 1 of a single visit study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Talissa Altes, MD, University of Missouri-Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
September 30, 2018
Study Completion (Actual)
October 31, 2018
Study Registration Dates
First Submitted
February 25, 2017
First Submitted That Met QC Criteria
February 28, 2017
First Posted (Actual)
March 1, 2017
Study Record Updates
Last Update Posted (Actual)
May 1, 2020
Last Update Submitted That Met QC Criteria
April 22, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
De-identified data will be shared with the sponsor
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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