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NCT Number: NCT07821398

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

Hyperpolarized 129 Xenon Gas

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. RBC Oscillation Imaging Amplitude Defect Percentage

    Time frame: Single study visit, Day 1

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

  2. Whole-Lung RBC Chemical Shift

    Time frame: Single study visit, Day 1

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

Sponsors and collaborators

Lead sponsor

Bastiaan Driehuys

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Harmonized Hyperpolarized 129Xe MRI for Noninvasive Assessment of Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis (ILD-PH/SSc)

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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