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

Phase 1

Recruiting

• Conditions: Other Lung Disease; Interstitial Lung Disease; Cystic Fibrosis; Pulmonary Infection; Asthma; Pulmonary Hypertension; COPD
• Interventions: Drug: Hyperpolarized Xe129

• Registration Number: NCT04624490
• Lead Sponsor: Mario Castro, MD, MPH

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-10-31
• Study Start: 2020-11-02
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-10-26
• Study Completion: 2026-10-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperpolarized 129Xe	Hyperpolarized Xe129	Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults.

Primary Outcome Measures

Name	Time	Method
RBC/Barrier Ratio	Day 1	Ratio of xenon signal dissolved in RBCs to xenon signal dissolved in Barrier Tissues

Secondary Outcome Measures

Name	Time	Method
ADC	Day 1	Apparent Diffusion Coefficient of Xenon Gas in the lungs
Ventilation Defect Percentage	Day 1	Percentage of the Lungs with ventilation signal below a threshold level

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States