Study of Airflow in the Lungs Using Helium MRI

NCT02154568 | Completed

• 2 other identifiers: 16885W81XWH-09-2-0027
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD; Healthy; Constrictive Bronchitis

Keywords

Hyperpolarized gas MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hyperpolarized helium MRI flow velocity map

  Day1

• Hyperpolarized helium-3 MRI flow velocity map

  Day 1

Study Arms (1)

Hyperpolarized helium MRI of the chest

EXPERIMENTAL

The purpose of this study is to look at the airflow in the lungs of healthy subjects and subjects with lung disease using Magnetic Resonance Imaging (MRI) with inhaled hyperpolarized helium-3 gas.

Drug: hyperpolarized helium-3 gas with MRI of the chest

Interventions

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.

Also known as: 3He hyperpolarized MRI

Hyperpolarized helium MRI of the chest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (2)

Snyder Translation Fontaine Research Center 480 Ray C. Hunt Drive

Charlottesville, Virginia, 22908, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yun M Shim, MD

  University of Virginia Department of Pulmonary and Critical Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: November 7, 2013
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (2)