Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease

Study Overview
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Brief Summary
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The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function.

Detailed Description
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This is an unblinded, open-label study with  160 subjects with diagnosed pulmonary disease and  100 healthy controls. Subjects to be enrolled will include males and females 18-80 years old. Evaluation will be on an outpatient basis. Imaging will be done on a single day and will involve administration of up to four 1-liter doses of HP 129Xe plus one 129Xe calibration dose ( 300-400mL HP 129Xe). In addition to 129Xe MRI, a series of anatomical conventional 1H MR images will be collected including a localizer scan, breath-hold spin echo image, and breath-hold steady-state free precession image to highlight the vasculature. All subjects will be evaluated at one center: The University of Kansas Medical Center, KS USA.

Official Title
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Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease

Conditions
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Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Pulmonary Hypertension, Pulmonary Infection, Other Lung Disease

Intervention / Treatment
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* Drug: Hyperpolarized Xe129


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Volunteers: Subject has no diagnosed pulmonary conditions Ability to read and understand English or Spanish Subjects with Lung Disease: Subject has a diagnosis of pulmonary dysfunction made by a physician No acute worsening of pulmonary function in the past 30 days Ability to read and understand English or Spanish Exclusion Criteria: MRI is contraindicated based on responses to MRI screening questionnaire Subject is pregnant or lactating Subject does not fit into 129Xe vest coil used for MRI Subject cannot hold his/her breath for 15-16 seconds Subject deemed unlikely to be able to comply with instructions during imaging Oxygen saturation <88% on room air or with supplemental oxygen Cognitive deficits that preclude ability to provide consent Institutionalization

Ages Eligible for Study
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Minimum Age: 3 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperpolarized 129Xe<br>Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults. | Drug: Hyperpolarized Xe129<br>* During MRI scanning, subject will inhale hyperpolarized xenon gas for a maximum of 16 seconds per scan, with a maximum of 4 MR scans + Calibration in a given imaging session.<br>* Other names: HP Xenon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC/Barrier Ratio | Ratio of xenon signal dissolved in RBCs to xenon signal dissolved in Barrier Tissues | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADC | Apparent Diffusion Coefficient of Xenon Gas in the lungs | Day 1 | 
| Ventilation Defect Percentage | Percentage of the Lungs with ventilation signal below a threshold level | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperpolarized 129Xe MRI