COPDNCT05816616
Hyperpolarized Xenon Functional Lung Imaging in COPD Patients Undergoing Targeted Lung Denervation
An observational study of COPD, run by Xemed LLC.
Trial summary
Targeted Lung Denervation (TLD) Therapy is intended to improve airway smooth muscle relaxation from the site of treatment all the way to the lung periphery, which may be beneficial in the treatment of patients with COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Functional imaging of the lungs using MagniXene (hyperpolarized xenon-129) MRI
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Apr 2030
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be selected from the pool of patients with severe COPD enrolled in Targeted Lung Denervation therapy AIFLOW-3 clinical trial ongoing at Temple University Hospital.
Who may be able to join
- Subjects are already consented and enrolled in the AIRFLOW-3 clinical trial at Temple University Hospital and are willing to participate in this sub-study for assessing functional lung changes from prior to post TLD treatment using hyperpolarized xenon-129 MRI.
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 with a BMI>35;
- Subjects with chest size larger than the bore of MRI machine from the study
About this study
Official title: Pilot Study of Hyperpolarized Xenon Functional Lung Imaging in COPD Patients Undergoing Targeted Lung Denervation
Targeted Lung Denervation (TLD) Therapy is intended to improve airway smooth muscle relaxation from the site of treatment all the way to the lung periphery, which may be beneficial in the treatment of patients with COPD. To better understand the physiological effects of this therapy, the investigators intend to conduct a functional magnetic resonance imaging study of the lung with HP 129Xe study in COPD patients undergoing this procedure. HP 129Xe provides valuable regional information about ventilation and gas exchange in both healthy and diseased lung.
Read the detailed description
This study will be assessing the treatment response using HP 129Xe MRI for patients undergoing Target Lung Denervation (TLD) in COPD patients. Subjects eligible to participate in this study are those who agree and have already consented to participate in the AIRFLOW-3 clinical trial for TLD treatment at Temple University Hospital. The intent of this study is to image lung function using HP 129Xe MRI in ten TLD subjects before and approximately three months post TLD procedure as an observational sub-study. Subjects willing to participate in this sub-study will have to consent to this study and plan for two MRI imaging sessions: one prior TLD and a follow-up at approximately three months post TLD procedure.
As part of this companion protocol at Penn, the aim is to image each subject twice, using a total of 2.5L of HP 129Xe gas administered over approximately 50 breaths during each visit. Using the dynamic image set acquired, the investigators will characterize each imaging voxel (approximately 4mm x 4mm x 4mm) in terms of its tidal volume (in mm3), functional residual capacity (in mm3), fractional ventilation (efficiency of gas exchange via ventilation, unit less), and what is defined as "arrival time", which can be also shown as 'tidal volume hysteresis', and corresponds to the area enclosed when the local tidal volume is plotted against the inhaled gas volume. The latter parameter is zero in a region that inflates and deflates perfectly in sync with the inhaled gas volume but grows in magnitude when the two are out of sync: e.g., in cases obstructed ventilation or air trapping. 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. Each imaging session will take approximately 30 minutes, including positioning in the MRI and inhalation of a small HP 129Xe dose for scanner calibration. The proposed dynamic HP 129Xe MRI technique allows for the quantification of fractional ventilation (FV), tidal volume (TV), functional residual capacity (FRC), arrival time (τ), apparent diffusion coefficient (ADC), and dissolved phase HP 129Xe information. Obtaining all of these parameters in a single scan session reduces the necessary amount of imaging gas while increasing accuracy by correcting artifacts associated with collateral ventilation and the slow filling of parenchyma in diseased lungs. Following the two imaging sessions, data will be analyzed and compared, including comparison with other lung function measuring techniques.
- Conditions
- COPD
- Being tested
- Functional imaging of the lungs using MagniXene (hyperpolarized xenon-129) MRI
- Keywords
- hyperpolarized xenon-129 MRI, COPD, Targeted Lung Denervation (TLD)
- 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.
Functional imaging of the lungs using MagniXene (hyperpolarized xenon-129) MRIDiagnostic test
Patients for this observational study will be selected on a voluntarily basis from the ongoing Airflow-3 interventional clinical trial at Temple University Hospital. For this observational sub-study, patients will have their lung function measured using hyperpolarized xenon-129 MRI prior to TLD treatment, and 90 days post-treatment for a better understanding of treatment effects. This sub-study does not influence in any way the patient treatment or the outcomes for the main Airflow-3 TLD clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| COPD-TLD patients | COPD patients to be treated with Targeted Lung Denervation and enrolled in Airflow-3 clinical trial at Temple University Hospital, and which are also willing to participate in hyperpolarized xenon imaging of their lungs prior and poste TLD treatment. Receives: Diagnostic Test: Functional imaging of the lungs using MagniXene (hyperpolarized xenon-129) MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in regional lung ventilation from pre-TLD baseline to three months post-TLD.
Fractional ventilation (FV) is defined as the ratio of inspired gas to residual gas volume and it will be measured using dynamic HP 129Xe MRI performed over approximately 50 breaths during normal respiratory cycle in which small amounts of xenon will be precisely administered. FV provides a quantitative and non-dimensional map of inhaled gas within the lungs and it is the most widely accepted quanititative measure of regional lung ventilation. The pre and post measurements will be entered into a general linear model to search for differences.
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Sep 2025 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Why it stopped: Did not received funding and it was not started.
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xemed LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Temple University, University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816616
- Sponsor's protocol ID
- 851758
- Status last verified
- Jan 2025
- First submitted
- 14 Mar 2023
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Hyperpolarized Xenon Functional Lung Imaging in COPD Patients Undergoing Targeted Lung Denervation
- ClinicalTrials.gov ID
- NCT05816616
- Acronym / sponsor ID
- 851758
- Conditions
- COPD
- Keywords
- hyperpolarized xenon-129 MRI, COPD, Targeted Lung Denervation (TLD)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Did not received funding and it was not started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xemed LLCIndustry (pharma, biotech, devices)
- Collaborators
- Temple University, University of Pennsylvania
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 18 Apr 2023 (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.
Targeted Lung Denervation (TLD) Therapy is intended to improve airway smooth muscle relaxation from the site of treatment all the way to the lung periphery, which may be beneficial in the treatment of patients with COPD. To better understand the physiological effects of this therapy, the investigators intend to conduct a functional magnetic resonance imaging study of the lung with HP 129Xe study in COPD patients undergoing this procedure. HP 129Xe provides valuable regional information about ventilation and gas exchange in both healthy and diseased lung.
Detailed description
This study will be assessing the treatment response using HP 129Xe MRI for patients undergoing Target Lung Denervation (TLD) in COPD patients. Subjects eligible to participate in this study are those who agree and have already consented to participate in the AIRFLOW-3 clinical trial for TLD treatment at Temple University Hospital. The intent of this study is to image lung function using HP 129Xe MRI in ten TLD subjects before and approximately three months post TLD procedure as an observational sub-study. Subjects willing to participate in this sub-study will have to consent to this study and plan for two MRI imaging sessions: one prior TLD and a follow-up at approximately three months post TLD procedure.
As part of this companion protocol at Penn, the aim is to image each subject twice, using a total of 2.5L of HP 129Xe gas administered over approximately 50 breaths during each visit. Using the dynamic image set acquired, the investigators will characterize each imaging voxel (approximately 4mm x 4mm x 4mm) in terms of its tidal volume (in mm3), functional residual capacity (in mm3), fractional ventilation (efficiency of gas exchange via ventilation, unit less), and what is defined as "arrival time", which can be also shown as 'tidal volume hysteresis', and corresponds to the area enclosed when the local tidal volume is plotted against the inhaled gas volume. The latter parameter is zero in a region that inflates and deflates perfectly in sync with the inhaled gas volume but grows in magnitude when the two are out of sync: e.g., in cases obstructed ventilation or air trapping. 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. Each imaging session will take approximately 30 minutes, including positioning in the MRI and inhalation of a small HP 129Xe dose for scanner calibration. The proposed dynamic HP 129Xe MRI technique allows for the quantification of fractional ventilation (FV), tidal volume (TV), functional residual capacity (FRC), arrival time (τ), apparent diffusion coefficient (ADC), and dissolved phase HP 129Xe information. Obtaining all of these parameters in a single scan session reduces the necessary amount of imaging gas while increasing accuracy by correcting artifacts associated with collateral ventilation and the slow filling of parenchyma in diseased lungs. Following the two imaging sessions, data will be analyzed and compared, including comparison with other lung function measuring techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD-TLD patients | – | Diagnostic Test: Functional imaging of the lungs using MagniXene (hyperpolarized xenon-129) MRICOPD patients to be treated with Targeted Lung Denervation and enrolled in Airflow-3 clinical trial at Temple University Hospital, and which are also willing to participate in hyperpolarized xenon imaging of their lungs prior and poste TLD treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from the pool of patients with severe COPD enrolled in Targeted Lung Denervation therapy AIFLOW-3 clinical trial ongoing at Temple University Hospital.
Key inclusion criteria (1 listed)
- Subjects are already consented and enrolled in the AIRFLOW-3 clinical trial at Temple University Hospital and are willing to participate in this sub-study for assessing functional lung changes from prior to post TLD treatment using hyperpolarized xenon-129 MRI.
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 |
|---|---|---|
| Functional imaging of the lungs using MagniXene (hyperpolarized xenon-129) MRIPatients for this observational study will be selected on a voluntarily basis from the ongoing Airflow-3 interventional clinical trial at Temple University Hospital. For this observational sub-study, patients will have their lung function measured using hyperpolarized xenon-129 MRI prior to TLD treatment, and 90 days post-treatment for a better understanding of treatment effects. This sub-study does not influence in any way the patient treatment or the outcomes for the main Airflow-3 TLD clinical trial. | Diagnostic test | COPD-TLD patients |
Primary outcome
Change in regional lung ventilation from pre-TLD baseline to three months post-TLD.
Time frame: 3-month
Fractional ventilation (FV) is defined as the ratio of inspired gas to residual gas volume and it will be measured using dynamic HP 129Xe MRI performed over approximately 50 breaths during normal respiratory cycle in which small amounts of xenon will be precisely administered. FV provides a quantitative and non-dimensional map of inhaled gas within the lungs and it is the most widely accepted quanititative measure of regional lung ventilation. The pre and post measurements will be entered into a general linear model to search for differences.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Xemed LLC.
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 1 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: withdrawn, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in regional lung ventilation from pre-TLD baseline to three months post-TLD. (time frame: 3-month). 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 20 Jan 2026.