Interstitial Lung DiseasePhase 2NCT07821398
Hyperpolarized Xenon MRI in Adults With Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis
A Phase 2 study testing Hyperpolarized 129 Xenon Gas in people with Interstitial Lung Disease and Pulmonary Hypertension, run by Bastiaan Driehuys.
Trial summary
This study aims to evaluate a noninvasive magnetic resonance imaging technique using hyperpolarized xenon gas to measure lung function in adults with interstitial lung disease, pulmonary hypertension, and systemic sclerosis. 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, Pulmonary Hypertension, Systemic Sclerosis
- What is being tested?
- Hyperpolarized 129 Xenon Gas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 20 Apr 2030
- 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
- Age ≥18 years at enrollment.
- Participant is willing and able to provide written informed consent.
- Able (in the Investigator's opinion) and willing to comply with all study requirements.
- Participant has or is suspected to have one of the following pulmonary conditions:
- Healthy volunteers: aged 18-30 years; no known cardiopulmonary disease; has not smoked tobacco products in the previous 5 years; smoking history, if any, is less than or equal to 5 pack-years; no history of using other inhaled products more than 1 time per week for > 1 year OR
- ILD-PH: ≥18 years; ILD diagnosis; precapillary PH by RHC (mPAP >20 mmHg, PVR >2 WU, PCWP ≤15 mmHg) within the specified window OR
- SSc: systemic sclerosis diagnosis with or without PH
Who cannot join
- Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for the participants to undergo MRI (for example: presence of an implanted or external MRI unsafe device that cannot be removed, body weight exceeding table limitations, inability to lie flat, or severe claustrophobia).
- Inability to hold breath for 10-15 seconds for required imaging or for completion of DLCO measurements.
- Active pulmonary infection or lung cancer.
- Recent respiratory infection or pulmonary disease exacerbation within 4 weeks of screening.
- Participants who are known to be pregnant or lactating.
- Concurrent enrollment and participation in a study which, in the opinion of the Investigator, would interfere with the study compliance, or outcome assessments or would prohibit the collection of the required data points.
About this study
Official title: Harmonized Hyperpolarized 129Xe MRI for Noninvasive Assessment of Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis (ILD-PH/SSc)
This study aims to evaluate a noninvasive magnetic resonance imaging technique using hyperpolarized xenon gas to measure lung function in adults with interstitial lung disease, pulmonary hypertension, and systemic sclerosis. Researchers will assess whether MRI measurements correlate with clinical measures of lung and vascular function.
- Being tested
- Hyperpolarized 129 Xenon Gas
- Keywords
- Interstitial Lung Disease, Pulmonary Hypertension, Magnetic Resonance Imaging, Systemic Sclerosis
- Medical subject headings
- Lung Diseases, Interstitial, Hypertension, Pulmonary, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129 Xenon GasDrug
Hyperpolarized xenon gas is inhaled during MRI to evaluate lung ventilation and gas exchange.
| Study group | Role | What they receive |
|---|---|---|
| Hyperpolarized Xenon MRI | Experimental | Participants undergo hyperpolarized Xenon MRI imaging and clinical assessments. Receives: Drug: Hyperpolarized 129 Xenon Gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy for Detection of Pulmonary Hypertension (sensitivity)
Sensitivity of pre-specified 129Xe MRI biomarkers for identifying pre-capillary pulmonary hypertension in participants with systemic sclerosis, using right-heart catheterization as the reference standard.
Measured: Single study visit, Day 1
Diagnostic Accuracy for Detection of Pulmonary Hypertension (specificity)
Specificity of pre-specified 129Xe MRI biomarkers for identifying pre-capillary pulmonary hypertension in participants with systemic sclerosis, using right-heart catheterization as the reference standard.
Measured: Single study visit, Day 1
Secondary outcomes (2)
RBC Oscillation Imaging Amplitude Defect Percentage
Percentage of lung volume exhibiting abnormal regional RBC oscillation amplitude as measured by hyperpolarized 129Xe MRI.
Measured: Single study visit, Day 1
Whole-Lung RBC Chemical Shift
Mean frequency difference between the center of the RBC resonance and the alveolar gas resonance.
Measured: Single study visit, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion20 Apr 2030 (estimated)
- Study completion20 Apr 2030 (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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bastiaan Driehuys
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Bastiaan Driehuys, Duke University
- Investigators
- Joseph Mammarappallil, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821398
- Sponsor's protocol ID
- Pro00120593
- Other IDs
- R01HL126771
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 15 Sep 2026
- 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonized Hyperpolarized 129Xe MRI for Noninvasive Assessment of Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis (ILD-PH/SSc)
- ClinicalTrials.gov ID
- NCT07821398
- Acronym / sponsor ID
- Pro00120593
- Keywords
- Interstitial Lung Disease, Pulmonary Hypertension, Magnetic Resonance Imaging, Systemic Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Bastiaan DriehuysUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 20 Apr 2030 (estimated)
- Study completion
- 20 Apr 2030 (estimated)
- First posted
- 15 Sep 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.
This study aims to evaluate a noninvasive magnetic resonance imaging technique using hyperpolarized xenon gas to measure lung function in adults with interstitial lung disease, pulmonary hypertension, and systemic sclerosis. Researchers will assess whether MRI measurements correlate with clinical measures of lung and vascular function.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperpolarized Xenon MRI | Experimental | Drug: Hyperpolarized 129 Xenon GasParticipants undergo hyperpolarized Xenon MRI imaging and clinical assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years at enrollment.
- Participant is willing and able to provide written informed consent.
- Able (in the Investigator's opinion) and willing to comply with all study requirements.
- Participant has or is suspected to have one of the following pulmonary conditions:
- Healthy volunteers: aged 18-30 years; no known cardiopulmonary disease; has not smoked tobacco products in the previous 5 years; smoking history, if any, is less than or equal to 5 pack-years; no history of using other inhaled products more than 1 time per week for > 1 year OR
Key exclusion criteria (6 listed)
- Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for the participants to undergo MRI (for example: presence of an implanted or external MRI unsafe device that cannot be removed, body weight exceeding table limitations, inability to lie flat, or severe claustrophobia).
- Inability to hold breath for 10-15 seconds for required imaging or for completion of DLCO measurements.
- Active pulmonary infection or lung cancer.
- Recent respiratory infection or pulmonary disease exacerbation within 4 weeks of screening.
- Participants who are known to be pregnant or lactating.
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 129 Xenon GasHyperpolarized xenon gas is inhaled during MRI to evaluate lung ventilation and gas exchange. | Drug | Hyperpolarized Xenon MRI |
Primary outcome
Diagnostic Accuracy for Detection of Pulmonary Hypertension (sensitivity)
Time frame: Single study visit, Day 1
Sensitivity of pre-specified 129Xe MRI biomarkers for identifying pre-capillary pulmonary hypertension in participants with systemic sclerosis, using right-heart catheterization as the reference standard.
Diagnostic Accuracy for Detection of Pulmonary Hypertension (specificity)
Time frame: Single study visit, Day 1
Specificity of pre-specified 129Xe MRI biomarkers for identifying pre-capillary pulmonary hypertension in participants with systemic sclerosis, using right-heart catheterization as the reference standard.
2 secondary outcomes
RBC Oscillation Imaging Amplitude Defect Percentage
Time frame: Single study visit, Day 1
Whole-Lung RBC Chemical Shift
Time frame: Single study visit, Day 1
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 15 Sep 2026.
- 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.
Joseph Mammarappallil principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperpolarized 129 Xenon Gas in people with Interstitial Lung Disease and Pulmonary Hypertension, run by Bastiaan Driehuys.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Sep 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.
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?
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?
Diagnostic Accuracy for Detection of Pulmonary Hypertension (sensitivity) (time frame: Single study visit, Day 1). The study lists 2 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 15 Sep 2026.