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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02154568
Other study ID # 16885
Secondary ID W81XWH-09-2-0027
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2013
Est. completion date July 1, 2025

Study information

Verified date March 2022
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date July 1, 2025
Est. primary completion date June 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Virginia Health System Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 1
Secondary Hyperpolarized helium MRI flow velocity map Spirometry (FEV1) Day1
Secondary Hyperpolarized helium MRI flow velocity map Spirometry (FVC) Day 1
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