Home › Emphysema › NCT07896902
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
Who can join
Ages 40 to 84 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Enrolled and randomized in BREATHE-3 to the Treatment arm or enrolled as a Control arm participant who has elected crossover treatment following BREATHE-3 Month 12. 2. Separate written BREATHE-Xe informed consent obtained prior to any sub-study procedures. 3. Able to perform coached breath-hold maneuvers of ≥10 seconds, as assessed by the site investigator. 4. Willing and able to travel to KUMC or UAB for all scheduled Xe-MRI sessions. 5. Eligible for MRI per local MRI safety screening, with no contraindications to MRI. Exclusion Criteria: 1. Any absolute contraindication to MRI, including ferromagnetic implants not approved for MRI, cardiac pacemaker or ICD not MRI-conditional, cochlear implants, severe claustrophobia, or any condition judged incompatible with safe MRI by the investigator. 2. Known allergy or hypersensitivity to xenon gas or components of the HP ¹²⁹Xe formulation. 3. SpO₂ \<88% at rest on the day of planned Xe-MRI, measured on the participant's usual oxygen (room air or standard supplemental oxygen per BREATHE-3 protocol or site standard of care). Supplemental oxygen is removed only for the preparation breaths and xenon inhalation, then resumed. 4\. Any medical condition that, in the investigator's opinion, would preclude safe participation or compromise imaging data integrity.
About the study
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.
What is being tested
- Hyperpolarized Xenon MRI (drug)
- Apreo BREATHE Airway Scaffold (device)
Sponsor: Apreo Health, Inc. · Participants: 15 · Started: 2026-10
Contact the study team
- Nina Mohmood · Phone: 650-326-2656
Official record on ClinicalTrials.gov — NCT07896902
Locations in the U.S.
| Alabama | University of Alabama at Birmingham, Birmingham |
| Kansas | University of Kansas Medical Center (KUMC), Kansas City (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.