Interstitial Lung DiseasePhase 2NCT06038630
129Xe MRI Cardiopulmonary
A Phase 2 study testing Hyperpolarized Xe129 and Oxygen Administration in people with Interstitial Lung Disease and Chronic Thromboembolic Pulmonary Hypertension, run by Bastiaan Driehuys at 1 site in United States.
Trial summary
The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe gas exchange MRI and to understand how they change in response to interventions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease, Chronic Thromboembolic Pulmonary Hypertension, Acute Pulmonary Embolism
- What is being tested?
- Hyperpolarized Xe129 and Oxygen Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 30 Jun 2028
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial)
- Outpatients of either gender, age > 18
- Willing and able to give informed consent and adhere to visit/protocol (Consent must be given before any study procedures are performed.)
- Subject has no diagnosed pulmonary conditions
- Subject has not smoked in the previous 5 years
- Smoking history, if any, is less than or equal to 5 pack-years
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- No history of using other inhaled products more than 1/week for > 1 year
- In-patient or outpatients of either sex, age > 18
- Willing and able to give informed consent and adhere to visit/protocol
- And one of the following:
- Patients who are scheduled to receive a red cell transfusion for anemia.
- Patients who are scheduled to undergo therapeutic phlebotomy to treat erythrocytosis or polycythemia
- Healthy volunteers undergoing voluntary whole blood donation (healthy volunteer inclusion criteria noted above)
- In-patient or outpatients of either sex, age > 18
- Willing and able to give informed consent and adhere to visit/protocol
- And one of the following categories (ILD, Dyspnea, CTEPH, or Healthy):
- Interstitial Lung Disease or Dyspnea
- Physician diagnosis of Interstitial Lung Disease by a pulmonologist using established criteria or physician referral of patient with dyspnea
- OR
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- Patients with a diagnosis of CTEPH, defined as mean PA pressure >20 mmHg with a pulmonary vascular resistance >2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation
- Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans
- OR
- Healthy Volunteer (criteria noted above)
- Inclusion Criteria for Acute or Chronic Pulmonary Embolism Patients:
- In-patient or outpatients of either sex, age > 18
- Willing and able to give informed consent and adhere to visit/protocol
- And one of the following categories (Acute or Chronic)
- Acute Pulmonary Embolism
- Patients presenting with acute PE 24-48hrs post-admission
- Willing to return after 3-6 months of anti-coagulation therapy
- OR
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- Patients with a diagnosis of CTEPH, defined as mean PA pressure >20 mmHg with a pulmonary vascular resistance >2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation
- Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans
Who cannot join
- Subjects presenting with any of the following will not be included in the trial:
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Resting O2 saturation <90% with maximum supplemental O2 delivered by nasal canula
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- Subject has history of any known ventricular cardiac arrhythmia
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- Subject has history of cardiac arrest within the last year
- Subject does not fit into 129Xe vest coil used for MRI
- Subject cannot hold his/her breath for 10 seconds
- Subject deemed unlikely to be able to comply with instructions during imaging
- Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Cody Blanton, 919-668-7575, cody.blanton@duke.edu
Jennifer Korzekwinski, 919-681-7362, jennifer.korzekwinski@duke.edu
About this study
Official title: 129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function
The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe gas exchange MRI and to understand how they change in response to interventions.
Read the detailed description
This study focuses on the markers that are derived from the interaction of 129Xe with pulmonary capillary red blood cells (RBCs). Specifically, the investigators focus on RBC transfer MRI, cardiogenic oscillations in 129Xe-RBC signal amplitude, and the 129Xe-RBC chemical shift.
In addition to healthy volunteers, the population to be studied will consist of patients scheduled to undergo either transfusion or phlebotomy, those with dyspnea, those with a physician diagnosis of interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonias (NSIP), chronic hypersensitivity pneumonitis (cHP), and sarcoid, as well as those with either chronic thromboembolic pulmonary hypertension (CTEPH) and acute pulmonary embolism.
- Conditions
- Interstitial Lung Disease, Chronic Thromboembolic Pulmonary Hypertension, Acute Pulmonary Embolism, Anemia, Polycythemia, Dyspnea
- Being tested
- Hyperpolarized Xe129, Oxygen Administration
- Medical subject headings
- Lung Diseases, Interstitial, Anemia, Polycythemia, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Xe129Drug
Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds.
Oxygen AdministrationOther
Oxygen administration
| Study group | Role | What they receive |
|---|---|---|
| Transfusion and Phlebotomy Patients | Active comparator | Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood. Receives: Drug: Hyperpolarized Xe129 |
| Oxygen Administration Patients | Active comparator | Individuals diagnosed with a chronic blood clot in their lungs and are planning on having surgery to remove it (CTEPH), or have an interstitial lung disease (ILD), or have dyspnea, or are a healthy volunteer. Receives: Drug: Hyperpolarized Xe129; Other: Oxygen Administration |
| Acute or Chronic Pulmonary Embolism Patients | Active comparator | Individuals recently diagnosed with a blood clot in their lungs. Receives: Drug: Hyperpolarized Xe129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis
The investigators will validate the Hb (hemoglobin) correction model in anemia patients pre/post transfusion and blood donors pre/post apheresis.
Measured: Up to 5 days pre/post transfusion or apheresis
Change in RBC (red blood cell) Chemical Shift After Oxygen Administration
To test the effects of oxygen on 129Xe MRI/MRS in healthy subjects, those with ILD, those with dyspnea, and patients with chronic thromboembolic pulmonary hypertension (CTEPH).
Measured: Baseline, 1 day
Change in RBC Oscillation Amplitude Post Therapy
Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.
Measured: Baseline, 3-6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start12 Jan 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bastiaan Driehuys
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Bastiaan Driehuys, Duke University
- Investigators
- Joseph Mammarappallil, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038630
- Sponsor's protocol ID
- Pro00113114
- Status last verified
- Feb 2026
- First submitted
- 8 Sep 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function
- ClinicalTrials.gov ID
- NCT06038630
- Acronym / sponsor ID
- Pro00113114
- Conditions
- Interstitial Lung Disease, Chronic Thromboembolic Pulmonary Hypertension, Acute Pulmonary Embolism, Anemia, Polycythemia, Dyspnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Bastiaan DriehuysUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Sep 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.
The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe gas exchange MRI and to understand how they change in response to interventions.
Detailed description
This study focuses on the markers that are derived from the interaction of 129Xe with pulmonary capillary red blood cells (RBCs). Specifically, the investigators focus on RBC transfer MRI, cardiogenic oscillations in 129Xe-RBC signal amplitude, and the 129Xe-RBC chemical shift.
In addition to healthy volunteers, the population to be studied will consist of patients scheduled to undergo either transfusion or phlebotomy, those with dyspnea, those with a physician diagnosis of interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonias (NSIP), chronic hypersensitivity pneumonitis (cHP), and sarcoid, as well as those with either chronic thromboembolic pulmonary hypertension (CTEPH) and acute pulmonary embolism.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transfusion and Phlebotomy Patients | Active comparator | Drug: Hyperpolarized Xe129Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood. |
| Oxygen Administration Patients | Active comparator | Drug: Hyperpolarized Xe129, Other: Oxygen AdministrationIndividuals diagnosed with a chronic blood clot in their lungs and are planning on having surgery to remove it (CTEPH), or have an interstitial lung disease (ILD), or have dyspnea, or are a healthy volunteer. |
| Acute or Chronic Pulmonary Embolism Patients | Active comparator | Drug: Hyperpolarized Xe129Individuals recently diagnosed with a blood clot in their lungs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- (Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial)
- Outpatients of either gender, age > 18
- Willing and able to give informed consent and adhere to visit/protocol (Consent must be given before any study procedures are performed.)
- Subject has no diagnosed pulmonary conditions
- Subject has not smoked in the previous 5 years
Key exclusion criteria (11 listed)
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Resting O2 saturation <90% with maximum supplemental O2 delivered by nasal canula
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- Subject has history of any known ventricular cardiac arrhythmia
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 Xe129Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds. | Drug | Acute or Chronic Pulmonary Embolism Patients, Oxygen Administration Patients, Transfusion and Phlebotomy Patients |
| Oxygen AdministrationOxygen administration | Other | Oxygen Administration Patients |
Primary outcome
Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis
Time frame: Up to 5 days pre/post transfusion or apheresis
The investigators will validate the Hb (hemoglobin) correction model in anemia patients pre/post transfusion and blood donors pre/post apheresis.
Change in RBC (red blood cell) Chemical Shift After Oxygen Administration
Time frame: Baseline, 1 day
To test the effects of oxygen on 129Xe MRI/MRS in healthy subjects, those with ILD, those with dyspnea, and patients with chronic thromboembolic pulmonary hypertension (CTEPH).
Change in RBC Oscillation Amplitude Post Therapy
Time frame: Baseline, 3-6 months post-treatment
Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.
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 4 Feb 2026.
- Individual participant dataSharing planned: Yes. A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI.
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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.
Joseph Mammarappallil, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperpolarized Xe129 and Oxygen Administration in people with Interstitial Lung Disease and Chronic Thromboembolic Pulmonary Hypertension, run by Bastiaan Driehuys 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 35 inclusion and 11 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 4 Feb 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Bastiaan Driehuys, PhD (919-684-7786, bastiaan.driehuys@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis (time frame: Up to 5 days pre/post transfusion or apheresis). The study lists 3 primary outcomes in all. 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 4 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.