Study of Airflow in the Lungs Using Helium MRI

Sponsor

University of Virginia (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02154568

Collaborator

(none)

Enrollment

Location

Arm

140

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COPD Healthy Constrictive Bronchitis	Drug: hyperpolarized helium MRI of the chest	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

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

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Jun 15, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Hyperpolarized helium MRI flow velocity map [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

Hyperpolarized helium MRI flow velocity map [Day1]
Spirometry (FEV1)
Hyperpolarized helium MRI flow velocity map [Day 1]
Spirometry (FVC)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia Health System	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Y. Michael Shim, MD, Associate Professor, University of Virginia

ClinicalTrials.gov Identifier:

NCT02154568

Other Study ID Numbers:

16885
W81XWH-09-2-0027

First Posted:

Jun 3, 2014

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Keywords provided by Y. Michael Shim, MD, Associate Professor, University of Virginia

Hyperpolarized gas MRI

Additional relevant MeSH terms:

Bronchitis

Study Results

No Results Posted as of Mar 21, 2022