[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423439":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":60,"collaborators":10,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":10,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CF and Non-CF Bronchiectasis",null,"In the first arm (Aims 1 \\& 2) Up to 50 subjects will be recruited-approximately 25 with normal FEV1 (\\>85% predicted) and 25 with mild to moderate disease. All subjects will be asked to undergo longitudinal (i.e., approximately annually) 129Xe and UTE MRI, spirometry, and lung clearance index (LCI) measurement.",[13],"Drug: Xenon",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy Subjects","Up to 50 age and sex matched control subjects (i.e., subjects with no known cardiopulmonary disorders) may also be recruited to provide a reference data set from healthy subjects for comparison.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Xenon","Subjects will be scanned on a commercial 3T whole-body MRI scanner equipped with high-performance gradient systems. Natural isotopic abundance or isotopically-enriched xenon gas (\\~86% 129Xe, Linde Inc.) will be used for all studies. Subjects will be positioned supine in the scanner with a 129Xe RF coil around their chests. Using conventional proton MRI and a breath-hold acquisition, \"scout\" images will be obtained to localize the subject for subsequent 129Xe acquisitions. 129Xe images will be acquired using the same breath-hold maneuver and a pulse sequence, covering the entire lung (acquisition time \\\u003C10 s, approximately 3-mm in-plane resolution, 15-mm slice thickness or less). Additional scans (sequences) may be performed. A maximum of 4 doses of 129Xe will be given throughout the study following the calibration dose.",[9,15],[25],"129Xe",[27],{"name":28,"affiliation":29,"role":30},"Zackary I Cleveland, PhD","CCHMC","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Penny A New, BBA","CONTACT","513-332-7931","penny.new@cchmc.org",{"name":38,"role":34,"phone":39,"phoneExt":10,"email":40},"Carrie Stevens, BS","513-636-9973","carrie.stevens@cchmc.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Penny New","RECRUITING","Cincinnati","Ohio","45229","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-84.51439,39.12711,{"lat":54,"lon":53},[57,58],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},{"name":59,"role":30,"phone":10,"phoneExt":10,"email":10},"Zackary Cleveland, PhD",{"type":30,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Zackary I. Cleveland, PhD","Principal Investigator","100423439","regional-phenotyping-of-cf-and-non-cf-bronchiectasis-100423439",false,"NCT04793867","Regional Phenotyping of CF and Non-CF Bronchiectasis","Regional Phenotyping of Cystic Fibrosis Lung Disease and Non-CF Bronchiectasis","Inclusion Criteria:\n\n* CF Patients: Diagnosis of CF based on sweat chloride \\>60 mMol\u002Fl\n* Presence of two disease causing CFTR mutations, or end organ manifestations of disease.\n* Age minimum 5 years.\n* Care provided by the CCHMC CF Care Center or other regional CF Care Centers if required to achieve recruitment goals.\n\nExclusion Criteria:\n\n* Patients meeting standard MRI exclusions criteria (non-MRI-compatible metal implants, claustrophobia, etc.)\n* Pregnancy or lactation.\n\nInclusion Criteria of Healthy Subjects:\n\n* Subjects 5 years of age and older with no known history of cardiopulmonary disease.\n\nExclusion Criteria of Healthy Subjects:\n\n* Patients meeting standard MRI exclusions criteria (non-MRI-compatible metal implants, claustrophobia, etc.)\n* Pregnancy or lactation.",true,"ALL","5 Years","100 Years",{"count":75,"type":76},100,"ESTIMATED","OBSERVATIONAL","The Investigators propose to study pediatric subjects who are diagnosed with cystic fibrosis (CF) and patients with non-CF bronchiectasis, with the goal of developing markers of CF lung disease severity, progression, and therapy response. The Investigator's central hypothesis is that image-based markers can forecast pathophysiology prior to spirometric changes.",[80,81],"Cystic Fibrosis","Non-CF Bronchiectasis",[80,83,84,81],"hyperpolarized xenon","LCI","2025-02-18",{"date":87,"type":88},"2025-02-20","ACTUAL",{"date":90,"type":88},"2021-02-08",{"date":92,"type":76},"2027-03-31",{"name":5,"class":6},1]