[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656078":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":30,"interventions":37,"overallOfficials":43,"centralContacts":23,"locations":23,"responsibleParty":47,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":23,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":23,"enrollmentInfo":65,"targetDuration":23,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":78,"whyStopped":23,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":23},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Single study visit, Day 1",{"measure":14,"description":15,"timeFrame":12},"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.",[17,20],{"measure":18,"description":19,"timeFrame":12},"RBC Oscillation Imaging Amplitude Defect Percentage","Percentage of lung volume exhibiting abnormal regional RBC oscillation amplitude as measured by hyperpolarized 129Xe MRI.",{"measure":21,"description":22,"timeFrame":12},"Whole-Lung RBC Chemical Shift","Mean frequency difference between the center of the RBC resonance and the alveolar gas resonance.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE",[31],{"label":32,"type":33,"description":34,"interventionNames":35},"Hyperpolarized Xenon MRI","EXPERIMENTAL","Participants undergo hyperpolarized Xenon MRI imaging and clinical assessments.",[36],"Drug: Hyperpolarized 129 Xenon Gas",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":23},"DRUG","Hyperpolarized 129 Xenon Gas","Hyperpolarized xenon gas is inhaled during MRI to evaluate lung ventilation and gas exchange.",[32],[44],{"name":45,"affiliation":5,"role":46},"Joseph Mammarappallil","PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Bastiaan Driehuys","Associate Professor of Radiology",[52],{"name":53,"class":54},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100656078","phase-2-hyperpolarized-xenon-mri-in-adults-with-pulmonary-hypertension-in-interstitial-lung-disease-and-systemic-sclerosis-100656078",false,"NCT07821398","Hyperpolarized Xenon MRI in Adults With Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis","Harmonized Hyperpolarized 129Xe MRI for Noninvasive Assessment of Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis (ILD-PH\u002FSSc)","Inclusion Criteria:\n\n* Age ≥18 years at enrollment.\n* Participant is willing and able to provide written informed consent.\n* Able (in the Investigator's opinion) and willing to comply with all study requirements.\n* Participant has or is suspected to have one of the following pulmonary conditions:\n* 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\n* ILD-PH: ≥18 years; ILD diagnosis; precapillary PH by RHC (mPAP \\>20 mmHg, PVR \\>2 WU, PCWP ≤15 mmHg) within the specified window OR\n* SSc: systemic sclerosis diagnosis with or without PH\n\nExclusion Criteria:\n\n* 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).\n* Inability to hold breath for 10-15 seconds for required imaging or for completion of DLCO measurements.\n* Active pulmonary infection or lung cancer.\n* Recent respiratory infection or pulmonary disease exacerbation within 4 weeks of screening.\n* Participants who are known to be pregnant or lactating.\n* 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.",true,"ALL","18 Years",{"count":66,"type":67},51,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","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.",[73,74,75],"Interstitial Lung Disease","Pulmonary Hypertension","Systemic Sclerosis",[73,74,77,75],"Magnetic Resonance Imaging","NOT_YET_RECRUITING","2026-09-10",{"date":81,"type":82},"2026-09-15","ACTUAL",{"date":84,"type":67},"2026-11-01",{"date":86,"type":67},"2030-04-20",{"name":49,"class":6}]