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Not yet recruitingNCT07821398Updated Sep 15, 2026

Hyperpolarized Xenon MRI in Adults With Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis

A Phase 2 interventional study of Hyperpolarized 129 Xenon Gas in Interstitial Lung Disease, Pulmonary Hypertension and Systemic Sclerosis, sponsored by Bastiaan Driehuys. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Bastiaan Driehuys · Phase 2, Interventional, and Basic science

Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. Researchers will assess whether MRI measurements correlate with clinical measures of lung and vascular function.

02

Conditions studied

  • Interstitial Lung Disease
  • Pulmonary Hypertension
  • Systemic Sclerosis

Keywords

  • Interstitial Lung Disease
  • Pulmonary Hypertension
  • Magnetic Resonance Imaging
  • Systemic Sclerosis
03

In context

Lung Diseases, Interstitial

680 studies on the registry are indexed under Lung Diseases, Interstitial; 246 are open to participants now.

This study's planned enrollment of 51 is below the median of 60 across 384 interventional studies indexed under Lung Diseases, Interstitial.

Browse Lung Diseases, Interstitial studies →

Lead sponsor

Bastiaan Driehuys is the lead sponsor of 18 studies on the registry; 9 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years at enrollment.
  • Participant is willing and able to provide written .
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (estimated)

Study arms

  • Experimental
    Hyperpolarized Xenon MRI

    Participants undergo hyperpolarized Xenon MRI imaging and clinical assessments.

    Drug: Hyperpolarized 129 Xenon Gas

Interventions

  • DrugHyperpolarized 129 Xenon Gas

    Hyperpolarized xenon gas is inhaled during MRI to evaluate lung ventilation and gas exchange.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Single study visit, Day 1

  2. 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.

    Time frame: Single study visit, Day 1

Secondary outcomes

  1. RBC Oscillation Imaging Amplitude Defect Percentage

    Percentage of lung volume exhibiting abnormal regional RBC oscillation amplitude as measured by hyperpolarized 129Xe MRI.

    Time frame: Single study visit, Day 1

  2. Whole-Lung RBC Chemical Shift

    Mean frequency difference between the center of the RBC resonance and the alveolar gas resonance.

    Time frame: Single study visit, Day 1

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Apr 2030, 41 months later.

Of 53 phase 2 interventional studies under Lung Diseases, Interstitial, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 71. This study's planned 41 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2026
First posted
Sep 15, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Apr 20, 2030
CompletionEst.
Apr 20, 2030
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07821398
Lead sponsor
Bastiaan Driehuys
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Bastiaan Driehuys (Associate Professor of Radiology, Duke University) — Sponsor-investigator
First posted
Sep 15, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Apr 20, 2030 (estimated)
Completion
Apr 20, 2030 (estimated)
Last update
Sep 15, 2026

Study contacts

Joseph Mammarappallil
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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