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Completed

NCT Number: NCT03068091

Assessment of Lung Movement With Computed Tomography (CT)

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.

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Key information

Conditions

Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chest CT

Device

Inspiration and expiration chest CT

Pulmonary Function Testing

Diagnostic Test

Measure lung function

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 1, 2017
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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