[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656153":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":30,"interventions":37,"overallOfficials":41,"centralContacts":45,"locations":51,"responsibleParty":68,"collaborators":23,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":23,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":23,"enrollmentInfo":80,"targetDuration":23,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":23,"overallStatus":54,"whyStopped":23,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Xe Gas-Exchange MRI","Images reflecting dissolved-phase xenon distribution in pulmonary tissues and blood obtained by xenon MRI","Through study completion, an average of 5 years",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Establish Aquisition Strategies for Xenon Ventilation Imaging","Ventilation defect percentage (i.e., hypoventilated lung volume) will be analyzed following the xenon MRI",{"measure":18,"description":19,"timeFrame":12},"Percentage difference between Xe MRIs repeated within the same-day","Quantitative outcomes from Xe MRI scans, like the ventilation defect percentage (i.e., hypoventilated lung volume), from within the same participant will be compared using paired statistical tests to assess the same-day repeatability.",{"measure":21,"description":22,"timeFrame":12},"Correlation between FEV1 and FEV1\u002FFVC from spirometry with ventilation-defect percentage from Xe MRI.","The correlation between FEV1 and FEV1\u002FFVC measured in liters and\u002For percent predicted from reference equations and the VDP (ventilation defect percentage) from Xe MRI will be determined.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE",[31],{"label":32,"type":33,"description":34,"interventionNames":35},"Hyperpolarized 129 Xenon","EXPERIMENTAL","Hyperpolarized xenon gas will be administered in doses of up to 1\u002F6TLC (based on either ATS calculations that utilize gender and height to determine the dose or plethysmography data) for participants under 18 years old and 1000 milliliters for adults per our previous research experience followed by a breath hold of up to 16 seconds",[36],"Drug: Hyperpolarized 129 Xenon",[38],{"type":39,"name":32,"description":34,"armGroupLabels":40,"otherNames":23},"DRUG",[32],[42],{"name":43,"affiliation":5,"role":44},"Laura Walkup, PhD","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":23,"email":50},"Ashley Borden, MPH","CONTACT","5136360143","ashley.borden@cchmc.org",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Cincinnati Children's Hospital Medical Center","RECRUITING","Cincinnati","Ohio","45229","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-84.51439,39.12711,{"lat":64,"lon":63},[67],{"name":47,"role":48,"phone":49,"phoneExt":23,"email":50},{"type":69,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100656153","phase-1-assessing-pulmonary-changes-in-hsct-100656153",false,"NCT07823036","Assessing Pulmonary Changes in HSCT","Assessing Pulmonary Changes in Hematopoietic Stem-Cell Transplantation Patients and Patients With Rare-Lung Diseases Using Hyperpolarized Xe MR Lung Imaging","Inclusion Criteria:\n\n* Ages 3 years and older\n\nExclusion Criteria:\n\n* Pregnancy or positive pregnancy test\n* Baseline oximetry at MRI visit of less than 90% on room air or less than 90% on a previously prescribed dosage of oxygen delivered by nasal cannula. In some cases of cardiorespiratory disease, if the participant is referred to this research study by their treating physician and considered stable for imaging, the cardiorespiratory criteria will be 5% of their clinical baseline. This should be documented in the research record upon referral of a participant that meets this scenario.\n* Any condition in the opinion of the investigator that would make the participant unable to tolerate the MRI procedure (e.g., neurocognitive delay, behavioral issues).\n* Standard MRI exclusions (e.g., metal, incompatible implants).",true,"ALL","3 Years",{"count":81,"type":82},550,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","This will be an un-blinded, open-label study of children and adults, including those who are being evaluated for or who have undergone HSCT, those with existing respiratory conditions and\u002For diagnosed gas-exchange impairment, and healthy control volunteers. The participants will be male or female between 3-17 years old (children) and adults age 18 and older.\n\nThe study objective is to:\n\n* To optimize the acquisition of images reflecting the \"dissolved-phase\" Xe distribution in the pulmonary tissues and blood (Xe gas-exchange MRI).\n* To develop and test Xe MRI acquisition strategies that separately image alveolar airspace distribution (ventilation), as well as Xe dissolved in pulmonary tissues versus red blood cells (RBCs).\n* To acquire images of Xe ventilation and dissolved-phase Xe regional distribution in the enrolled participants.\n* To understand the same-day variability of Xe MRI techniques.\n* To determine the relationship between Xe MRI and clinical measures such as pulmonary-function-test (PFT) parameters or other biological biomarkers.\n* To develop and optimize strategies for Xe MRI in young children including those who are unable to follow the inhalation and breath-hold instructions typical of the Xe MRI procedure.",[89,90,91],"HSCT","Respiratory","Gas Exchange Impairment","2026-09-10",{"date":94,"type":95},"2026-09-16","ACTUAL",{"date":97,"type":95},"2024-07-24",{"date":99,"type":82},"2029-07",{"name":5,"class":6},1]