Air TrappingEarly Phase 1BREATHE-XeNCT07896902
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
A Early Phase 1 study testing Hyperpolarized Xenon MRI and Apreo BREATHE Airway Scaffold in people with Air Trapping and Emphysema, run by Apreo Health, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- Air Trapping, Emphysema, Hyperinflation
- What is being tested?
- Hyperpolarized Xenon MRI and Apreo BREATHE Airway Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Nov 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 4. Any medical condition that, in the investigator's opinion, would preclude safe participation or compromise imaging data integrity.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cindy Holtz contact
United States2 sites, 2 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Surya Bhatt, MD
- Not yet recruiting
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, 66160
Maykol Postigo, MD
About this 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.
Read the detailed description
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.
- Conditions
- Air Trapping, Emphysema, Hyperinflation
- Being tested
- Hyperpolarized Xenon MRI, Apreo BREATHE Airway Scaffold
- Keywords
- Lung Function, Xenon, MRI
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Xenon MRIDrug
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 ScaffoldDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| XENOVIEW | Other | 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). Receives: Drug: Hyperpolarized Xenon MRI; Device: Apreo BREATHE Airway Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (1)
Ventilation
Change in whole-lung VDP
Measured: 1 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air TrappingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Up to 15 participants will be enrolled and imaged, with a target of approximately 10 providing complete, interpretable imaging for the primary analysis. Participants will be enrolled at two participating BREATHE-Xe sites, the University of Kansas Medical Center (KUMC; Site \[108\]) and the University of Alabama at Birmingham (UAB; Site \[106\]). Enrollment will not be site-capped. Each site may enroll eligible participants until the overall BREATHE-Xe enrollment target is reached.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apreo Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham, University of Kansas Medical Center
- Responsible party
- Sponsor
- Investigators
- Peter Niedbalski, PhD, Study director, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896902
- Sponsor's protocol ID
- CIP-0028-04
- Acronym
- BREATHE-Xe
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will report aggregate results in publications. Individual patient data is not reported.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
- ClinicalTrials.gov ID
- NCT07896902
- Acronym / sponsor ID
- BREATHE-Xe / CIP-0028-04
- Conditions
- Air Trapping, Emphysema, Hyperinflation
- Keywords
- Lung Function, Xenon, MRI
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Apreo Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham, University of Kansas Medical Center
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Up to 15 participants will be enrolled and imaged, with a target of approximately 10 providing complete, interpretable imaging for the primary analysis. Participants will be enrolled at two participating BREATHE-Xe sites, the University of Kansas Medical Center (KUMC; Site [108]) and the University of Alabama at Birmingham (UAB; Site [106]). Enrollment will not be site-capped. Each site may enroll eligible participants until the overall BREATHE-Xe enrollment target is reached.
| Arm | Type | Receives |
|---|---|---|
| XENOVIEW | Other | Drug: Hyperpolarized Xenon MRI, Device: Apreo BREATHE Airway ScaffoldHyperpolarized 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). |
Who may qualify
- Ages
- 40 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- 4. Any medical condition that, in the investigator's opinion, would preclude safe participation or compromise imaging data integrity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized Xenon MRIHyperpolarized 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. | Drug | XENOVIEW |
| Apreo BREATHE Airway ScaffoldThe 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. | Device | XENOVIEW |
Primary outcome
Primary Endpoint
Time frame: 6 Months
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.
1 secondary outcome
Ventilation
Time frame: 1 and 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. We will report aggregate results in publications. Individual patient data is not reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cindy Holtz contact
Peter Niedbalski, PhD study director
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hyperpolarized Xenon MRI and Apreo BREATHE Airway Scaffold in people with Air Trapping and Emphysema, run by Apreo Health, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Mohmood (650-326-2656, Nina.Mohmood@ApreoHealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.