Recruiting
Early Phase 1

Apreo BREATHE

Sponsor:

Apreo Health, Inc.

Code:

NCT07896902

Conditions

Air Trapping

Emphysema

Hyperinflation

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized Xenon MRI

Apreo BREATHE Airway Scaffold

Study Details

Brief 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.

Conditions

Air Trapping

Emphysema

Hyperinflation

Study ID

NCT07896902

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: XENOVIEW

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).

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.

Primary outcome measure

  • Primary Endpoint [ Time Frame: 6 Months ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator:

Surya Bhatt, MD

More Information

Sponsor

Apreo Health, Inc.

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Keywords

  • Lung Function
  • Xenon
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Apreo Health, Inc. on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.