Assessment of Lung Movement With Computed Tomography (CT)

NCT03068091 | Completed Results FDA Device

• 1 other identifier: 2006114
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Keywords

Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lung Motion: Lobar Strain Which is a Ratio

  Study visit 1 of a single visit study

Study Arms (1)

Pulmonary Assessment

OTHER

All participants will undergo a Chest CT scan and pulmonary function testing

Device: Chest CT; Diagnostic Test: Pulmonary Function Testing

Interventions

Chest CT DEVICE

Inspiration and expiration chest CT

Pulmonary Assessment

Pulmonary Function Testing DIAGNOSTIC_TEST

Measure lung function

Pulmonary Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects less than 18 years of age

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Talissa Altes
• Organization: University of Missouri

ALTEST@HEALTH.MISSOURI.EDU

573 882 1026

Study Officials

• Talissa Altes, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of the Department of Radiology

Model Details: All participants will undergo CT and pulmonary function testing.

Study Record Dates

• First Submitted: February 25, 2017
• First Posted: March 1, 2017
• Study Start: July 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: October 31, 2018
• Last Updated: May 1, 2020
• Results First Posted: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)