Assessment of Lung Movement With Computed Tomography (CT)

Interstitial Lung Disease Clinical Trial

Official title:

Assessment of Lung Movement With CT in Healthy Subjects and Patients With ILD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068091
• Other study ID #: 2006114
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: April 2020
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Device:
• Chest CT
Inspiration and expiration chest CT

Diagnostic Test:
• Pulmonary Function Testing
Measure lung function

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Henry M. Jackson Foundation for the Advancement of Military Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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	Study visit 1 of a single visit study