Healthy Clinical Trial
Official title:
Flow Quantification in the Human Airways Using Hyperpolarized Helium 3 MRI
Verified date | March 2022 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia Health System | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
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 |
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