NCT04624490

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Mario Castro, MD, MPH · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

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.

Conditions

• Asthma
• COPD
• Interstitial Lung Disease
• Cystic Fibrosis
• Pulmonary Hypertension
• Pulmonary Infection
• Other Lung Disease

Interventions

Type	Name	Description
DRUG	Hyperpolarized Xe129	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.

Timeline

• Start date: 2020-11-02
• Primary completion: 2025-10-26
• Completion: 2026-10-26
• First posted: 2020-11-10
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study