Functional Applications of Hyperpolarized 129Xe MRI

Study Overview
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Brief Summary
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The overall objectives of our study are to determine the capabilities of hyperpolarized 129Xe MRI to measure lung function and its potential to sensitively detect pulmonary disease and its progression in COPD. We hypothesize that measurement of alveolar surface area, septal thickness, and capillary transit time measured with hyperpolarized 129Xe will correlate better with quality of life measures in COPD subjects than traditional diagnostic measures such as spirometry and Computed Tomography.

Official Title
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Functional Applications of Hyperpolarized 129Xe MRI

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Hyperpolarized 129Xe gas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-75 For Healthy nonsmoker subjects: No current physician diagnosed medical disease requiring active medication No smoking history, defined as less than 100 cigarettes smoked in a lifetime Normal spirometry: FEV1/FVC ≥ 0.70, FEV1 ≥ 80% predicted For Subjects who have participated in the COPDGene Study Post-bronchodilator spirometry: FEV1 > 40% predicted Exclusion Criteria: MR contraindications: e.g., electrical implants such as cardiac pacemakers, ferromagnetic implants such as prostheses, claustrophobia Pregnancy or suspected pregnancy Use of continuous oxygen Use of antibiotics and/or systemic corticosteroids (new prescription or increased dose) for an exacerbation of lung disease or any lung infection in the past four weeks Uncontrolled cancer, as defined as ongoing radiation therapy, ongoing chemotherapy A heart attack in the past three months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with and without COPD<br>All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function. | Drug: Hyperpolarized 129Xe gas<br>* 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Statistics of Healthy Subjects | Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region. | 4 years | 
| Differences Between Healthy and Diseased COPD Subjects. | Hyperpolarized 129Xe MRI measures of disease severity in GOLD Stage 1-3 subjects are more highly correlated with physical disabilities associated with their pulmonary disease than traditional tests of pulmonary function. | 4 years | 
| Spatial Heterogeneity | Determine the degree to which the spatial heterogeneity of regional 129Xe measurements of pulmonary function in a single individual correlates with physical manifestations of disease severity. We hypothesize that measures of spatial heterogeneity will correlate highly with physical disability. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD