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

Mario Castro, MD, MPH

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: Hyperpolarized Xe129

Study type: Interventional

Funder types: Other

Identifiers

NCT04624490

STUDY00146119

Details and patient eligibility

About

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

Full description

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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260 participants in 1 patient group

Hyperpolarized 129Xe

Experimental group

Description:

Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults.

Treatment:

Drug: Hyperpolarized Xe129