An Early Phase 1 interventional study of Hyperpolarized Xenon MRI and Apreo BREATHE Airway Scaffold in Air Trapping, Emphysema and Hyperinflation, sponsored by Apreo Health, Inc.. Recruiting at 2 sites in United States. Open to participants aged 40 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Apreo Health, Inc. · Early Phase 1, Interventional, and Basic science
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.
BREATHE-Xe is a prospective, exploratory ancillary sub-study of BREATHE-3 using hyperpolarized ¹²⁹Xe MRI to characterize regional ventilation and gas exchange changes following treatment with the Apreo BREATHE System. The study will evaluate whether treatment reduces whole-lung ventilation defect percent (VDP) and whether changes occur preferentially within implanted airway regions; whether treatment is associated with changes in gas exchange at the alveolar-capillary level; how regional ventilation changes relate to CT, spirometric, and plethysmographic changes observed in BREATHE-3; and whether baseline imaging metrics may identify predictors of treatment response. All analyses are descriptive. Findings are intended to support mechanistic interpretation of BREATHE-3 results and to generate hypotheses for future studies.
382 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 245 interventional studies indexed under Emphysema.
Browse Emphysema studies →Apreo Health, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
4. Any medical condition that, in the investigator's opinion, would preclude safe participation or compromise imaging data integrity.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hyperpolarized ¹²⁹Xe (HP ¹²⁹Xe) gas (XENOVIEW, Polarean; NDA 214375), administered by inhalation as an MRI signal agent. Produced on-site immediately prior to use under site-held INDs: IND 151978 (KUMC); IND 178832 (UAB).
Drug: Hyperpolarized Xenon MRI · Device: Apreo BREATHE Airway Scaffold
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.
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.
Primary Endpoint
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.
Time frame: 6 Months
Ventilation
Change in whole-lung VDP
Time frame: 1 and 12 Months
Plan to share: No — We will report aggregate results in publications. Individual patient data is not reported.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Apreo Health, Inc.