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RECRUITING
NCT07896902
EARLY_PHASE1

Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema

Sponsor: Apreo Health, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DEVICE

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