Interstitial Lung DiseaseNCT03068091
Assessment of Lung Movement With Computed Tomography (CT)
A study testing Chest CT and Pulmonary Function Testing in people with Interstitial Lung Disease, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Chest CT and Pulmonary Function Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65212
About this study
Official title: 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.
Read the 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.
- Conditions
- Interstitial Lung Disease
- Being tested
- Chest CT, Pulmonary Function Testing
- Keywords
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest CTDevice
Inspiration and expiration chest CT
Pulmonary Function TestingDiagnostic test
Measure lung function
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Assessment | Other | All participants will undergo a Chest CT scan and pulmonary function testing Receives: Device: Chest CT; Diagnostic Test: Pulmonary Function Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Motion as Assessed by CT
A computer algorithm will compare the inspiration and expiration CT scans to determine regional lung motion.
Measured: Study visit 1 of a single visit study
Secondary outcomes (1)
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
Measured: Study visit 1 of a single visit study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start1 Jul 2017
- Primary completion30 Sep 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo CT and pulmonary function testing.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Principal investigator, Talissa Altes, MD, University of Missouri-Columbia
- Investigators
- Talissa Altes, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068091
- Sponsor's protocol ID
- 2006114
- Status last verified
- Apr 2020
- First submitted
- 25 Feb 2017
- Last updated
- 1 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be shared with the sponsor
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lung Movement With CT in Healthy Subjects and Patients With ILD
- ClinicalTrials.gov ID
- NCT03068091
- Acronym / sponsor ID
- 2006114
- Conditions
- Interstitial Lung Disease
- Keywords
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Posted 1 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo CT and pulmonary function testing.
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Assessment | Other | Device: Chest CT, Diagnostic Test: Pulmonary Function TestingAll participants will undergo a Chest CT scan and pulmonary function testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest CTInspiration and expiration chest CT | Device | Pulmonary Assessment |
| Pulmonary Function TestingMeasure lung function | Diagnostic test | Pulmonary Assessment |
Primary outcome
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.
1 secondary outcome
Lung Motion: Lobar Strain Which is a Ratio
Time frame: Study visit 1 of a single visit study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with the sponsor
Related trials for Interstitial Lung Disease
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
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Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
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RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talissa Altes, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest CT and Pulmonary Function Testing in people with Interstitial Lung Disease, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Motion as Assessed by CT (time frame: Study visit 1 of a single visit study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.