Study of Airflow in the Lungs Using Helium MRI

Healthy Clinical Trial

Official title:

Flow Quantification in the Human Airways Using Hyperpolarized Helium 3 MRI

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
• 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
• 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.

Related Conditions & MeSH terms

• Bronchitis
• Constrictive Bronchitis
• COPD
• Healthy

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