Assessment of Lung Movement With Computed Tomography (CT)

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: Interstitial Lung Disease
• Intervention / Treatment: Device: Chest CT; Diagnostic test: Pulmonary Function Testing

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

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Columbia

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pulmonary Assessment; All participants will undergo a Chest CT scan and pulmonary function testing	Device: Chest CT; Inspiration and expiration chest CT; Diagnostic test: Pulmonary Function Testing; Measure lung function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Investigators: Principal Investigator: Talissa Altes, MD, University of Missouri-Columbia

Study record dates

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

• Keywords: Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• 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