Assessment of Lung Movement With Computed Tomography (CT)

Not Applicable

Completed

• Conditions: Interstitial Lung Disease
• Interventions: Device: Chest CT; Diagnostic Test: Pulmonary Function Testing

• Registration Number: NCT03068091
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study First Submitted: 2017-02-25
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-01
• Study Start: 2017-07-01
• Primary Completion: 2018-09-30
• Study Completion: 2018-10-31
• Results First Submitted: 2020-03-25
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Results First Posted: 2020-05-01
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary Assessment	Pulmonary Function Testing	All participants will undergo a Chest CT scan and pulmonary function testing
Pulmonary Assessment	Chest CT	All participants will undergo a Chest CT scan and pulmonary function testing

Primary Outcome Measures

Name	Time	Method
Lung Motion as Assessed by CT	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 Outcome Measures

Name	Time	Method
Lung Motion: Lobar Strain Which is a Ratio	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

Trial Locations

Locations (1)

University of Missouri-Columbia; 🇺🇸 Columbia, Missouri, United States