COPDNCT02154568
Study of Airflow in the Lungs Using Helium MRI
A study testing hyperpolarized helium-3 gas with MRI of the chest in people with COPD and Healthy, run by University of Virginia at 2 sites in United States.
Trial summary
Computer simulations are being developed to predict air flow abnormalities in the airways of patients with lung disease. The purpose of this study is to obtain actual gas flow measurements in the lungs of healthy patients and patients with lung disease and use these measurements to validate the computer models. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Healthy, Constrictive Bronchitis
- What is being tested?
- hyperpolarized helium-3 gas with MRI of the chest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2013to 26 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy subjects:
- Normal PFT values: FEV1 > 90% predicted; and Forced vital capacity (FVC) > 90% predicted
- Normal chest x-ray (CXR)
- Medical history: No active pulmonary symptoms (cough, shortness of breath, sputum); Negative history of pulmonary disease; Negative smoking history (never smoked)
- Pulmonary Disease Subjects:
- PFT values: FEV1/FVC < 70% (indicative of obstruction); and 30% < FEV1 < 50% predicted
Show all 11Show fewer
- CXR normal except hyperinflation
- Symptoms - chronic shortness of breath
- All test subjects, healthy and with COPD should have similar physical anthropometric characteristics:
- Similar age with age difference less than 3 years
- Similar height (within 3-4 inches)
Who cannot join
- Any condition for which a MRI procedure is contraindicated.
- Presence of any non-MRI compatible metallic material in the body, such as pacemakers, metallic clips, etc.
- Likelihood of claustrophobia
- Chest circumference greater than that of the helium MR coil.
- Pregnancy, by report of subject. Clinically in the Department of radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Snyder Translation Fontaine Research Center 480 Ray C. Hunt Drive
Charlottesville, Virginia, 22908
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: Flow Quantification in the Human Airways Using Hyperpolarized Helium 3 MRI
Computer simulations are being developed to predict air flow abnormalities in the airways of patients with lung disease. The purpose of this study is to obtain actual gas flow measurements in the lungs of healthy patients and patients with lung disease and use these measurements to validate the computer models.
Read the detailed description
The Biotechnology High Performance Computing Software Applications Institute (BHSAI) of the Department of Defense (DoD) is studying airflow in the lungs using computational fluid dynamics in order to characterize disease-specific airflow patterns and provide useful information for medical applications. To validate these models, they are seeking to obtain experimental data of airflow in human lungs, both healthy and diseased. An assessment of airflow can be obtained by using hyperpolarized noble gas (HNG) magnetic resonance imaging (MRI) or, more specifically, hyperpolarized helium-3 (HHe) MRI in conjunction with flow-encoding schemes that are well-established in conventional proton MRI
Four chronic obstructive pulmonary disease (COPD) patients and four healthy subjects will undergo pulmonary function tests (PFTs), computed tomography (CT) scan covering the mouth, neck, and chest, and hyperpolarized helium 3 MRI. Before and after the MRI scans, three spirometry readings will be taken while the subject is lying in the same position as in the MR scanners. Data will be analyzed by the BHSAI. UVa will provide the de-identified raw image data and the de-identified results of the spirometry and other tests to BHSAI
- Conditions
- COPD, Healthy, Constrictive Bronchitis
- Being tested
- hyperpolarized helium-3 gas with MRI of the chest
- Keywords
- Hyperpolarized gas MRI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperpolarized helium-3 gas with MRI of the chestDrug
Also called 3He hyperpolarized MRI
Using hyperpolarized helium as an inhaled gaseous contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.
| Study group | Role | What they receive |
|---|---|---|
| Hyperpolarized helium MRI of the chest | Experimental | The purpose of this study is to look at the airflow in the lungs of healthy subjects and subjects with lung disease using Magnetic Resonance Imaging (MRI) with inhaled hyperpolarized helium-3 gas. Receives: Drug: hyperpolarized helium-3 gas with MRI of the chest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperpolarized helium MRI flow velocity map
Using hyperpolarized helium as an inhaled contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.
Measured: Day 1
Secondary outcomes (2)
Hyperpolarized helium MRI flow velocity map
Spirometry (FEV1)
Measured: Day1
Hyperpolarized helium-3 MRI flow velocity map
Spirometry (FVC)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study start7 Nov 2013
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Y. Michael Shim, MD, University of Virginia
- Investigators
- Yun M Shim, MD, Principal investigator, University of Virginia Department of Pulmonary and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154568
- Sponsor's protocol ID
- 16885
- Other IDs
- W81XWH-09-2-0027
- Status last verified
- Mar 2026
- First submitted
- 30 May 2014
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Quantification in the Human Airways Using Hyperpolarized Helium 3 MRI
- ClinicalTrials.gov ID
- NCT02154568
- Acronym / sponsor ID
- 16885
- Conditions
- COPD, Healthy, Constrictive Bronchitis
- Keywords
- Hyperpolarized gas MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 7 Nov 2013 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Computer simulations are being developed to predict air flow abnormalities in the airways of patients with lung disease. The purpose of this study is to obtain actual gas flow measurements in the lungs of healthy patients and patients with lung disease and use these measurements to validate the computer models.
Detailed description
The Biotechnology High Performance Computing Software Applications Institute (BHSAI) of the Department of Defense (DoD) is studying airflow in the lungs using computational fluid dynamics in order to characterize disease-specific airflow patterns and provide useful information for medical applications. To validate these models, they are seeking to obtain experimental data of airflow in human lungs, both healthy and diseased. An assessment of airflow can be obtained by using hyperpolarized noble gas (HNG) magnetic resonance imaging (MRI) or, more specifically, hyperpolarized helium-3 (HHe) MRI in conjunction with flow-encoding schemes that are well-established in conventional proton MRI
Four chronic obstructive pulmonary disease (COPD) patients and four healthy subjects will undergo pulmonary function tests (PFTs), computed tomography (CT) scan covering the mouth, neck, and chest, and hyperpolarized helium 3 MRI. Before and after the MRI scans, three spirometry readings will be taken while the subject is lying in the same position as in the MR scanners. Data will be analyzed by the BHSAI. UVa will provide the de-identified raw image data and the de-identified results of the spirometry and other tests to BHSAI
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperpolarized helium MRI of the chest | Experimental | Drug: hyperpolarized helium-3 gas with MRI of the chestThe purpose of this study is to look at the airflow in the lungs of healthy subjects and subjects with lung disease using Magnetic Resonance Imaging (MRI) with inhaled hyperpolarized helium-3 gas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy subjects:
- Pulmonary Disease Subjects:
- All test subjects, healthy and with COPD should have similar physical anthropometric characteristics:
Key exclusion criteria (5 listed)
- Any condition for which a MRI procedure is contraindicated.
- Presence of any non-MRI compatible metallic material in the body, such as pacemakers, metallic clips, etc.
- Likelihood of claustrophobia
- Chest circumference greater than that of the helium MR coil.
- Pregnancy, by report of subject. Clinically in the Department of radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging.
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 |
|---|---|---|
| hyperpolarized helium-3 gas with MRI of the chestAlso: 3He hyperpolarized MRIUsing hyperpolarized helium as an inhaled gaseous contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea. | Drug | Hyperpolarized helium MRI of the chest |
Primary outcome
Hyperpolarized helium MRI flow velocity map
Time frame: Day 1
Using hyperpolarized helium as an inhaled contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.
2 secondary outcomes
Hyperpolarized helium MRI flow velocity map
Time frame: Day1
Hyperpolarized helium-3 MRI flow velocity map
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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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.
Yun M Shim, MD principal investigator
University of Virginia Department of Pulmonary and Critical Care Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperpolarized helium-3 gas with MRI of the chest in people with COPD and Healthy, run by University of Virginia at 2 sites 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 11 inclusion and 5 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hyperpolarized helium MRI flow velocity map (time frame: Day 1). 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 17 Mar 2026.