Clinical trial NCT02154568: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD
Healthy
Constrictive Bronchitis
Keywords: Hyperpolarized gas MRI
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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.

Primary outcomes:
measure: Hyperpolarized helium MRI flow velocity map
timeFrame: Day 1
Secondary outcomes:
measure: Hyperpolarized helium MRI flow velocity map
timeFrame: Day1
measure: Hyperpolarized helium MRI flow velocity map
timeFrame: Day 1
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
References: