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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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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

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)

Conditions: Interstitial Lung Disease, Pulmonary Hypertension, Systemic Sclerosis
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 groups in NCT07821398
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.

1 Nov 202620 Apr 2030

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)

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

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
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Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
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Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
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Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial
Interstitial Lung Disease (ILD), Suspected Interstitial Lung Disease
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Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
Interstitial Lung Disease (ILD), Fibrotic Interstitial Lung Disease

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