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Study of Airflow in the Lungs Using Helium MRI

This study is currently recruiting participants.
Verified October 2017 by Y. Michael Shim, MD, University of Virginia
Sponsor:
ClinicalTrials.gov Identifier:
NCT02154568
First Posted: June 3, 2014
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Y. Michael Shim, MD, University of Virginia
  Purpose
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.

Condition Intervention
COPD Healthy Constrictive Bronchitis Drug: hyperpolarized helium MRI of the chest

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Flow Quantification in the Human Airways Using Hyperpolarized Helium 3 MRI

Further study details as provided by Y. Michael Shim, MD, University of Virginia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Spirometry (FEV1) [ Time Frame: Day 1 ]
  • Spirometry (FVC) [ Time Frame: Day 1 ]

Estimated Enrollment: 10
Study Start Date: November 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperpolarized helium MRI of the chest Drug: hyperpolarized helium MRI of the chest
Using hyperpolarized helium as an inhaled gaseous contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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): NCT02154568


Contacts
Contact: Rachel Dieterich, RN 434-243-6074 rrd8w@virginia.edu
Contact: Marie D Burdick 434-243-7363 mdb5b@virginia.edu

Locations
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Rachel Dieterich, RN    434-243-6074    rrd8w@virginia.edu   
Contact: Marie D Burdick    434-243-7363    mdb5b@virginia.edu   
Principal Investigator: Mike Shim, MD         
Sponsors and Collaborators
University of Virginia
  More Information

Responsible Party: Y. Michael Shim, MD, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT02154568     History of Changes
Other Study ID Numbers: 16885
W81XWH-09-2-0027 ( Other Grant/Funding Number: US Army Medical Research Acquisition Activity )
First Submitted: May 30, 2014
First Posted: June 3, 2014
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by Y. Michael Shim, MD, University of Virginia:
Hyperpolarized gas MRI

Additional relevant MeSH terms:
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections