Xenon MRI test for lung changes after Apreo BREATHE airway treatment in emphysema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an exploratory sub-study of the BREATHE-3 trial using hyperpolarized 129Xe MRI to characterize regional ventilation and gas exchange after Apreo BREATHE airway scaffold treatment. It aims to see if the treatment reduces regional ventilation defects and how these changes relate to CT and lung function measurements from BREATHE-3. All analyses are descriptive to support mechanistic interpretation and generate hypotheses for future research. Participants must be enrolled in BREATHE-3 and able to undergo multi-session Xe-MRI at participating sites. The study collects imaging data to potentially identify predictors of response.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Kansas Medical Center (KUMC)
  Kansas City, Kansas, United States Not yet recruiting

Study contacts

• Study coordinator: Nina Mohmood
• Email: Nina.Mohmood@ApreoHealth.com
• Phone: 650-326-2656

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.