COPDPhase 1NCT05433961
Functional and Structural Assessment of Endobronchial Valve Recipients Using Dynamic Hyperpolarized Xenon-129 MRI
A Phase 1 study testing MagniXene Hyperpolarized Xenon MRI in people with COPD, run by Xemed LLC at 1 site in United States.
Trial summary
This study proposes to use hyperpolarized xenon-129 Magnetic Resonance Imaging (MRI) to study lung function of COPD patients who will receive endobronchial valve (EBV) therapy as part of their clinical standard-of-care. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- MagniXene Hyperpolarized Xenon MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to 11 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients scheduled to receive endobronchial valve therapy
- Patient is conscious, cooperative and agrees to return for scheduled visits and tests
Who cannot join
- Patients less than 18 years old
- Patients known to be pregnant - a positive pregnancy test will be used to respectively exclude pregnant patients
- Any known contraindication to MRI examination
- Anyone with an implanted metal device
- Inability to provide informed consent
- A language, communication, cognitive or behavioral impairment that might interfere with fully informed participation in the study.
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- History of uncompensated organ failure (i.e. organ failure that is not stabilized through medical intervention), which will be assessed by the PI.
- Homelessness or other unstable living situation
- Active drug or alcohol dependence
- Claustrophobia
- Subjects weighting more than 300 pounds.
- Subjects with chest size larger than the bore of MRI machine from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study proposes to use hyperpolarized xenon-129 Magnetic Resonance Imaging (MRI) to study lung function of COPD patients who will receive endobronchial valve (EBV) therapy as part of their clinical standard-of-care. Once inhaled, HP xenon can provide information to imagers regarding functionality across specific regions of the lungs through the assessment of the replacement of air during the normal breathing cycle, how much oxygen is in the airspaces, and if the normal spongy tissue structure has been compromised by lung disease. Pre- (baseline) and post-EBV (follow-up) lung function imaging with HPXe will potentially lead to be better understand disease progression and treatment mechanism.
Read the detailed description
This study will be assessing the pulmonary function of COPD patients receiving endobronchial valve (EBV) therapy as part of their clinical care by using HP 129Xe MRI in an effort to evaluate the imaging technique's performance in identifying abnormal lung function and micromorphology in patients receiving this therapy. HP Xe MRI study visits will last 1-2 hours for each subject, with the possibility of multiple follow-ups in longitudinal studies. The investigators plan to recruit volunteer patients who are scheduled to receive EBV therapy for the treatment of COPD as part of their clinical standard-of-care. Patients will be imaged at at least two time point, pre-EBV (baseline), and ~45 days post-EBV (follow-up).
Subjects will provide a brief medical history and perform pulmonary function testing (PFT) prior to inhalation of HP xenon-129. If a subject has performed a PFT at the Hospital of the University of Pennsylvania or Temple University Hospital within one month of the study visit and the results are accessible by the research team, subjects will not be required to repeat PFTs for the purpose of imaging.
During a typical HXe MRI session, subjects will first be imaged using standard 1H MRI to generate an anatomical reference image. This will be followed by the inhalation of a small amount (~200 ml) of HP 129Xe from a Tedlar™ bag to perform a frequency calibration, as well as determine the effective flip-angle to be used for the subject. Finally, the subject will sequentially inhale up to 50 breaths of hyperpolarized 129Xe from a gas mixing apparatus designed to oxygenate and dilute the gas, maintaining near normoxic conditions and approximately 10% xenon concentration. During this period, the lungs will be continuously imaged using a 3D sequence and a very low flip-angle (~3 degrees) pulse. The subject will be coached to maintain a reasonably steady breathing cadence of 10-15 breaths per minute, depending on their size and natural breathing rate, but will be otherwise unconstrained with respect to breath timing and volume.
- Conditions
- COPD
- Being tested
- MagniXene Hyperpolarized Xenon MRI
- Keywords
- endobroncial valve, hyperpolarized xenon, lung MRI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagniXene Hyperpolarized Xenon MRIDrug
Magnetic Resonance Imaging of lung function using Hyperpolarized Xenon as a contrast agent.
| Study group | Role | What they receive |
|---|---|---|
| Hyperpolarized Xenon MRI assessment of lung function in endobronchial valve treated COPD patients | Experimental | Volunteer patients scheduled for receiving endobronchial valve treatment as part of clinical care will be imaged with hyperpolarized xenon prior and post EBV for assessing lung function and improvement. Receives: Drug: MagniXene Hyperpolarized Xenon MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function changes from baseline (pre) to follow-up (post) EBV procedure as measured with hyperpolarized xenon MRI.
Endobronchial valve receiving patients will have HPXe MRI sessions for assessing lung function parameters as measured from inhaled hyperpolarized xenon distribution inside the lungs. Fractional ventilation will be obtained based on the signal build up for dynamic breathing of HP 129Xe and room air. TV and FRC will be determined based on the signal build up at inhalation and the gas remaining in the lung at exhalation. τ will be determined by the signal intensity reaching other parts of the lung relative to the signal intensity in the trachea. ADC will be determined using diffusion sensitizing gradients according to standard imaging protocols. Additionally, dissolved phase MR imaging of HP 129Xe will be assessed in order to obtain information regarding microstructural abnormalities that affect gas uptake into the blood. All these parameters are mapped as 3D lung images, and they will be compared between baseline and follow-up session.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start20 Oct 2023
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Why it stopped: Regulatory Compliance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xemed LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Kevin Ma, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433961
- Sponsor's protocol ID
- 8511358
- Status last verified
- Sep 2025
- First submitted
- 22 Jun 2022
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Structural Assessment of Endobronchial Valve Recipients Using Dynamic Hyperpolarized Xenon-129 MRI
- ClinicalTrials.gov ID
- NCT05433961
- Acronym / sponsor ID
- 8511358
- Conditions
- COPD
- Keywords
- endobroncial valve, hyperpolarized xenon, lung MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Regulatory Compliance
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Xemed LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 27 Jun 2022 (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.
This study proposes to use hyperpolarized xenon-129 Magnetic Resonance Imaging (MRI) to study lung function of COPD patients who will receive endobronchial valve (EBV) therapy as part of their clinical standard-of-care. Once inhaled, HP xenon can provide information to imagers regarding functionality across specific regions of the lungs through the assessment of the replacement of air during the normal breathing cycle, how much oxygen is in the airspaces, and if the normal spongy tissue structure has been compromised by lung disease. Pre- (baseline) and post-EBV (follow-up) lung function imaging with HPXe will potentially lead to be better understand disease progression and treatment mechanism.
Detailed description
This study will be assessing the pulmonary function of COPD patients receiving endobronchial valve (EBV) therapy as part of their clinical care by using HP 129Xe MRI in an effort to evaluate the imaging technique's performance in identifying abnormal lung function and micromorphology in patients receiving this therapy. HP Xe MRI study visits will last 1-2 hours for each subject, with the possibility of multiple follow-ups in longitudinal studies. The investigators plan to recruit volunteer patients who are scheduled to receive EBV therapy for the treatment of COPD as part of their clinical standard-of-care. Patients will be imaged at at least two time point, pre-EBV (baseline), and ~45 days post-EBV (follow-up).
Subjects will provide a brief medical history and perform pulmonary function testing (PFT) prior to inhalation of HP xenon-129. If a subject has performed a PFT at the Hospital of the University of Pennsylvania or Temple University Hospital within one month of the study visit and the results are accessible by the research team, subjects will not be required to repeat PFTs for the purpose of imaging.
During a typical HXe MRI session, subjects will first be imaged using standard 1H MRI to generate an anatomical reference image. This will be followed by the inhalation of a small amount (~200 ml) of HP 129Xe from a Tedlar™ bag to perform a frequency calibration, as well as determine the effective flip-angle to be used for the subject. Finally, the subject will sequentially inhale up to 50 breaths of hyperpolarized 129Xe from a gas mixing apparatus designed to oxygenate and dilute the gas, maintaining near normoxic conditions and approximately 10% xenon concentration. During this period, the lungs will be continuously imaged using a 3D sequence and a very low flip-angle (~3 degrees) pulse. The subject will be coached to maintain a reasonably steady breathing cadence of 10-15 breaths per minute, depending on their size and natural breathing rate, but will be otherwise unconstrained with respect to breath timing and volume.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperpolarized Xenon MRI assessment of lung function in endobronchial valve treated COPD patients | Experimental | Drug: MagniXene Hyperpolarized Xenon MRIVolunteer patients scheduled for receiving endobronchial valve treatment as part of clinical care will be imaged with hyperpolarized xenon prior and post EBV for assessing lung function and improvement. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD patients scheduled to receive endobronchial valve therapy
- Patient is conscious, cooperative and agrees to return for scheduled visits and tests
Key exclusion criteria (12 listed)
- Patients less than 18 years old
- Patients known to be pregnant - a positive pregnancy test will be used to respectively exclude pregnant patients
- Any known contraindication to MRI examination
- Anyone with an implanted metal device
- Inability to provide informed consent
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 |
|---|---|---|
| MagniXene Hyperpolarized Xenon MRIMagnetic Resonance Imaging of lung function using Hyperpolarized Xenon as a contrast agent. | Drug | Hyperpolarized Xenon MRI assessment of lung function in endobronchial valve treated COPD patients |
Primary outcome
Lung function changes from baseline (pre) to follow-up (post) EBV procedure as measured with hyperpolarized xenon MRI.
Time frame: 90 days
Endobronchial valve receiving patients will have HPXe MRI sessions for assessing lung function parameters as measured from inhaled hyperpolarized xenon distribution inside the lungs. Fractional ventilation will be obtained based on the signal build up for dynamic breathing of HP 129Xe and room air. TV and FRC will be determined based on the signal build up at inhalation and the gas remaining in the lung at exhalation. τ will be determined by the signal intensity reaching other parts of the lung relative to the signal intensity in the trachea. ADC will be determined using diffusion sensitizing gradients according to standard imaging protocols. Additionally, dissolved phase MR imaging of HP 129Xe will be assessed in order to obtain information regarding microstructural abnormalities that affect gas uptake into the blood. All these parameters are mapped as 3D lung images, and they will be compared between baseline and follow-up session.
Results and safety
The study was stopped early (reason given: Regulatory Compliance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kevin Ma, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MagniXene Hyperpolarized Xenon MRI in people with COPD, run by Xemed LLC at 1 site 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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Regulatory Compliance). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function changes from baseline (pre) to follow-up (post) EBV procedure as measured with hyperpolarized xenon MRI. (time frame: 90 days). 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 30 Sep 2025.