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

STUDY00146119

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

2020-11-02

2025-10-26

2026-10-26

Recruiting

Early phase I

260

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 260, 'type': 'ESTIMATED'}}

2024-06-10