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Completed

NCT Number: NCT02154568

Study of Airflow in the Lungs Using Helium 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Snyder Translation Fontaine Research Center 480 Ray C. Hunt Drive, Charlottesville, Virginia, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hyperpolarized helium-3 gas with MRI of the chest

Drug

Using hyperpolarized helium as an inhaled gaseous contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.

Other names: 3He hyperpolarized MRI

Primary outcomes

  1. 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 outcomes

  1. Hyperpolarized helium MRI flow velocity map

    Time frame: Day1

    Spirometry (FEV1)

  2. Hyperpolarized helium-3 MRI flow velocity map

    Time frame: Day 1

    Spirometry (FVC)

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Flow Quantification in the Human Airways Using Hyperpolarized Helium 3 MRI

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2014
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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