Harmonized Hyperpolarized 129Xe MRI for Noninvasive Assessment of Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis (ILD-PH/SSc)
| Registry | NCT07821398 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, basic science |
| Enrollment | 51 (Estimated) |
| Sponsor | Bastiaan Driehuys (Other); collaborators: National Heart, Lung, and Blood Institute (NHLBI) |
| Conditions | Interstitial Lung Disease, Pulmonary Hypertension, Systemic Sclerosis |
| Interventions | Hyperpolarized 129 Xenon Gas (Drug) |
| Dates | start 2026-11-01 (estimated), primary completion 2030-04-20 (estimated), completion 2030-04-20 (estimated), first posted 2026-09-15, last updated 2026-09-15 |
Related Papers Related Patents Related Grants Related Experts
All trials for Interstitial Lung Disease All trials for Pulmonary Hypertension All trials of Hyperpolarized 129 Xenon Gas
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Hyperpolarized Xenon MRI | Experimental | Drug: Hyperpolarized 129 Xenon Gas | Participants undergo hyperpolarized Xenon MRI imaging and clinical assessments. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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.
NIH grants: R01HL126771