- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02154568
Study of Airflow in the Lungs Using Helium MRI
Flow Quantification in the Human Airways Using Hyperpolarized Helium 3 MRI
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia Health System
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Charlottesville, Virginia, United States, 22908
- Snyder Translation Fontaine Research Center 480 Ray C. Hunt Drive
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
- 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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hyperpolarized helium MRI of the chest
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.
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Using hyperpolarized helium as an inhaled gaseous contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hyperpolarized helium MRI flow velocity map
Time Frame: Day1
|
Spirometry (FEV1)
|
Day1
|
|
Hyperpolarized helium-3 MRI flow velocity map
Time Frame: Day 1
|
Spirometry (FVC)
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yun M Shim, MD, University of Virginia Department of Pulmonary and Critical Care Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16885
- W81XWH-09-2-0027 (Other Grant/Funding Number: US Army Medical Research Acquisition Activity)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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