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Recruiting Phase 1 NCT04624490

NCT04624490 Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease

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Clinical Trial Summary
NCT ID NCT04624490
Status Recruiting
Phase Phase 1
Sponsor Mario Castro, MD, MPH
Condition Asthma
Study Type INTERVENTIONAL
Enrollment 260 participants
Start Date 2020-11-02
Primary Completion 2025-10-26

Trial Parameters

Condition Asthma
Sponsor Mario Castro, MD, MPH
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 260
Sex ALL
Min Age 3 Years
Max Age N/A
Start Date 2020-11-02
Completion 2025-10-26
Interventions
Hyperpolarized Xe129

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Brief Summary

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

Eligibility Criteria

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

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