[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547346":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":46,"centralContacts":50,"locations":56,"responsibleParty":74,"collaborators":32,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":32,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":32,"studyType":92,"phases":93,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":58,"whyStopped":32,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Iowa","OTHER",[8,17,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Normal Subjects","ACTIVE_COMPARATOR","Healthy subjects, with no lung diagnosis, who are non-smokers.",[13,14,15,16],"Diagnostic Test: Spirometry","Diagnostic Test: Contrast Lung Computed Tomography (CT) Scan","Diagnostic Test: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan","Drug: 129Xe MRI scans",{"label":18,"type":19,"description":20,"interventionNames":21},"Post Lung Transplant with normal functioning","EXPERIMENTAL","Subjects who have had a lung transplant and now have normal lung function",[13,14,15,16],{"label":23,"type":19,"description":24,"interventionNames":25},"Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)","Subjects who have had a lung transplant that now have CLAD",[13,14,15,16],[27,33,37,41],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIAGNOSTIC_TEST","Spirometry","Spirometry measures lung function, specifically the amount and\u002For speed of air that can be inhaled and exhaled.",[9,23,18],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Contrast Lung Computed Tomography (CT) Scan","CT scan of the lungs using contrast",[9,23,18],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan","MRI will be taken while subject is lying on their back breathing 100% oxygen.",[9,23,18],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":32},"DRUG","129Xe MRI scans","MRI will be taken while subject is lying on their back breathing room oxygen and taking a breath of 129Xe and holding it for a few seconds.",[9,23,18],[47],{"name":48,"affiliation":5,"role":49},"Sean Fain, Ph.D","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":32,"email":55},"Sean Fain, Ph.D.","CONTACT","319 356 4832","sean-fain@uiowa.edu",[57],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Iowa City","Iowa","52242","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-91.53017,41.66113,{"lat":68,"lon":67},[71],{"name":72,"role":53,"phone":73,"phoneExt":32,"email":55},"Sean Fail, PhD","319-356-4832",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Sean Fain","Professor","100547346","phase-1-chronic-lung-allograft-dysfunction-mri-study-100547346",false,"NCT06406777","Chronic Lung Allograft Dysfunction MRI Study","Validation of MRI, CT and Pulmonary Function Tests for Early Detection of Chronic Lung Allograft Dysfunction","All subjects-Inclusion Criteria:\n\n* Ages 18-80\n* English Speaking Subjects\n* Willingness and ability to provide informed consent\n* Non-smoker\n\nLung transplant patients-inclusion criteria:\n\n* \\>\u002F= 6 months from lung transplant\n* History of bilateral lung transplant\n\nCLAD-free patients-inclusion criteria:\n\n* Stable spirometry with FEV1 \\> 90% of baseline value (average of 2 best values) and forced mid-expiratory flow (FEF) (25-75) \\> 75% of baseline\n* Total Lung Capacity (TLC) \\> 90 % of baseline\n* Post-transplant chest radiograph without significant abnormality\n* No evidence of on-going lung infection or allograft rejection\n\nEarly CLAD patients-inclusion criteria:\n\n* FEV1 \\\u003C 80% of baseline value (average of 2 best values)\n* Follow up 6-months or decline in lung function (20% decrease in FEV1 without evidence of infection or acute rejection)\n\nExclusion Criteria:\n\n* SAO2 drops below 90% (in absence of mechanical failure) during normal tidal breathing\n* Unilateral diaphragm paralysis\n* Evidence of acute illness on day of study\n* Evidence of restrictive lung disease\n* Dependence on supplemental oxygen\n* History of cardiac disease\n* Pregnancy (self-declared)\n* Lactating women\n* Participants with metal objects in their body\n* Known contraindication to MRI examination\n* Systolic blood pressure reading of \\\u003C 100 mmHg or \\> 200 mmHg\n* Diastolic blood pressure reading of \\\u003C60 mmHg or \\> 100 mmHg",true,"ALL","18 Years","80 Years",{"count":90,"type":91},100,"ESTIMATED","INTERVENTIONAL",[94,95],"PHASE1","PHASE2","This studies purpose is to confirm the efficacy and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan, this will enhance understanding of CLAD pathophysiology. Moreover, this project is foundational to performing additional studies to establish if novel MRI imaging can serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients.",[98],"Chronic Lung Allograft Dysfunction Lung MRI (CLAD)",[100],"Lung Transplant","2025-03-24",{"date":103,"type":104},"2025-03-27","ACTUAL",{"date":106,"type":104},"2025-03-20",{"date":108,"type":91},"2028-09",{"name":76,"class":6},1]