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RecruitingEarly Phase 1

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

Apreo Health, Inc. · with University of Alabama at Birmingham, University of Kansas Medical Center · NCT07896902

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–84 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Early Phase 1
Target enrollment
15
US sites recruiting
1
Study start
October 2026
Record last updated
October 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Hyperpolarized Xenon MRI; Apreo BREATHE Airway Scaffold

Conditions: Air Trapping; Emphysema; Hyperinflation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.
  • Separate written BREATHE-Xe informed consent obtained prior to any sub-study procedures.
  • Able to perform coached breath-hold maneuvers of ≥10 seconds, as assessed by the site investigator.
  • Willing and able to travel to KUMC or UAB for all scheduled Xe-MRI sessions.
  • Eligible for MRI per local MRI safety screening, with no contraindications to MRI.

Exclusion Criteria

  • 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.
  • 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.
  • Any medical condition that, in the investigator's opinion, would preclude safe participation or compromise imaging data integrity.

Recruiting US locations

  • University of Alabama at Birmingham

    Birmingham, AL 35294

    Site contact: Surya Bhatt, MD

Study contacts (from the official record)

  • Nina Mohmood · 650-326-2656 · Nina.Mohmood@ApreoHealth.com
  • Cindy Holtz · CindyHoltz@ApreoHealth.com
All phase 1 studies in Alabama →
Xenon MRI to Evaluate Changes to Lung Function Following… (NCT07896902) | Bored Studies