search
Back to results

Study of Airflow in the Lungs Using Helium MRI

Primary Purpose

COPD, Healthy, Constrictive Bronchitis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hyperpolarized helium MRI of the chest
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COPD focused on measuring Hyperpolarized gas MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Virginia Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperpolarized helium MRI of the chest

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hyperpolarized helium MRI flow velocity map
Spirometry (FEV1)
Hyperpolarized helium MRI flow velocity map
Spirometry (FVC)

Full Information

First Posted
May 30, 2014
Last Updated
March 4, 2022
Sponsor
University of Virginia
search

1. Study Identification

Unique Protocol Identification Number
NCT02154568
Brief Title
Study of Airflow in the Lungs Using Helium MRI
Official Title
Flow Quantification in the Human Airways Using Hyperpolarized Helium 3 MRI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Healthy, Constrictive Bronchitis
Keywords
Hyperpolarized gas MRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperpolarized helium MRI of the chest
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
hyperpolarized helium MRI of the chest
Intervention Description
Using hyperpolarized helium as an inhaled gaseous contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.
Primary Outcome Measure Information:
Title
Hyperpolarized helium MRI flow velocity map
Description
Using hyperpolarized helium as an inhaled contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Hyperpolarized helium MRI flow velocity map
Description
Spirometry (FEV1)
Time Frame
Day1
Title
Hyperpolarized helium MRI flow velocity map
Description
Spirometry (FVC)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Airflow in the Lungs Using Helium MRI

We'll reach out to this number within 24 hrs