Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Lung Movement With Computed Tomography (CT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03068091
Recruitment Status : Completed
First Posted : March 1, 2017
Results First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Information provided by (Responsible Party):
Talissa Altes, MD, University of Missouri-Columbia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Device: Chest CT Diagnostic Test: Pulmonary Function Testing Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will undergo CT and pulmonary function testing.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Lung Movement With CT in Healthy Subjects and Patients With ILD
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068091


Locations
Layout table for location information
United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Henry M. Jackson Foundation for the Advancement of Military Medicine
Investigators
Layout table for investigator information
Principal Investigator: Talissa Altes, MD University of Missouri-Columbia
  Study Documents (Full-Text)

Documents provided by Talissa Altes, MD, University of Missouri-Columbia:
Study Protocol and Statistical Analysis Plan  [PDF] April 26, 2017

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Talissa Altes, MD, Professor and Chair of the Department of Radiology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03068091    
Other Study ID Numbers: 2006114
First Posted: March 1, 2017    Key Record Dates
Results First Posted: May 1, 2020
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with the sponsor

Layout table for additional information
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
Keywords provided by Talissa Altes, MD, University of Missouri-Columbia:
Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases