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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Primary Endpoint — 6 Months
  The primary endpoint is the within-participant change in whole-lung VDP from baseline to Month 6, summarized descriptively. Ventilation defect percentage (VDP) will be defined as the percentage of total lung volume with ¹²⁹Xe signal intensity below 60% of the whole-lung mean signal intensity. A reduction in VDP is consistent with improvement in regional ventilation distribution following treatment. Given the small sample size, the median change will be reported as the primary summary measure, with the mean, 95% confidence interval, SD, and range also reported. No success threshold will be applied.

Trial sites (2)

More Apreo Health, Inc. trials in the USA

Other trials for the same condition