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Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
Sponsor: Apreo Health, Inc.
Summary
The objective of this study is to provide a regional, mechanistic characterization of pulmonary ventilation changes following treatment with the Apreo BREATHE System, using hyperpolarized ¹²⁹Xe MRI, in BREATHE-3 participants. BREATHE-Xe is designed to generate mechanistic signals regarding whether airway scaffolds reduce ventilation defects, improve gas exchange, and correlate with CT and spirometric/plethysmographic changes observed in BREATHE-3. Findings support mechanistic interpretation and future hypothesis generation.
Key Details
Gender
All
Age Range
40 Years - 84 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-10
Completion Date
2028-11
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Hyperpolarized Xenon MRI
Hyperpolarized Xenon MRI (HP ¹²#Xe) is a radiation-free imaging technique that boosts signal strength to create high-resolution images of how gas moves through the lungs. By tracking inhaled gas across separate breath-holds, it measures airflow blockage, tissue transfer efficiency, and gas uptake by red blood cells, while a washout test maps how well the lungs clear gas. It has been applied to characterize pulmonary impairment in COPD and emphysema and to detect regional ventilation changes following bronchoscopic interventions.
Apreo BREATHE Airway Scaffold
The experimental treatment involves placement of up to 6 Apreo BREATHE Airway Scaffolds (up to 3 per lung), in a single procedure using bronchoscopy and fluoroscopy. Treatment group subjects will also receive optimal medical management (OMM). The BREATHE Airway Scaffold implant procedure occurs under the BREATHE-3 main study. This procedure is not part of the BREATHE-Xe study, which focuses on changes in regional ventilation.
Locations (2)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States