[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054496":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":49,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":10,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LAM",null,"Patients with tissue diagnosis of LAM may be admitted for evaluation every six months, or as deemed necessary for research",[13],"Device: Toshibia Aquilion One CT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Toshibia Aquilion One CT","The Toshiba Aquilion ONE CT system is currently being used for studies in both general CT radiology and CT cardiac imaging. One of the unique aspects of the Aquilion ONE CT system is its ability to acquire whole organ volume images in a single rotation by utilizing an x-ray detector that is configured as 320 detector rows with a 0.5 mm width, providing a z-axis coverage of 16 cm of anatomy. In line with the evolutionary changes to CT systems, the Aquilion ONE will be upgraded with new technology that will expand its capabilities. The changes being made to the Aquilion ONE will provide enhancements to image acquisition capabilities, reduce ionizing radiation dose, and improve subject access to the system. All of these features assist in enhancing the safety of the currently installed Aquilion ONE CT system.",[9],[21],{"name":22,"affiliation":23,"role":24},"Joel Moss, M.D.","National Heart, Lung, and Blood Institute (NHLBI)","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Tatyana A Worthy, R.N.","CONTACT","(301) 827-1376","worthyt@mail.nih.gov",{"name":22,"role":28,"phone":32,"phoneExt":10,"email":33},"(301) 496-1597","mossj@nhlbi.nih.gov",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":10},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-77.10026,38.98067,{"lat":47,"lon":46},{"type":50,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100054496","study-of-the-disease-process-of-lymphangioleiomyomatosis-100054496",false,"NCT00001465","Study of the Disease Process of Lymphangioleiomyomatosis","Characterization of the Pathogenesis of Lymphangioleiomyomatosis (LAM)","* INCLUSION CRITERIA:\n\nGeneral admission criteria for patients include one or both of the following:\n\nFindings on lung biopsy diagnostic of LAM;\n\nFindings on chest x-ray and\u002For chest computed axial tomography consistent with LAM.\n\nPatients with TSC and pulmonary LAM will be included in the study.\n\nNormal non-smokers in the control group are defined as individuals who have not smoked for greater than or equal to 1 year and have no systemic or pulmonary disease.\n\nNormal smokers defined as individuals with no systemic or pulmonary disease, who have smoked for greater than or equal to 1 year and have normal chest x-ray and normal pulmonary function tests may be included if needed as controls for a similar population of patients with LAM.\n\nPregnant and or nursing women including pregnant minors may be included in accordance with Federal Regulations at Subpart B of 45 CFR 46. Subjects who are pregnant and or nursing will be excluded from procedures during their pregnancy that are greater than minimal risk, until they are no longer pregnant and\u002For nursing. A minor participant with a positive pregnancy test result will be informed promptly. The result will be discussed in a sensitive and developmentally appropriate manner with the minor, including explanation of the result, assessment of safety, and referral for appropriate follow-up care. The participant will be informed of the limits of confidentiality. The study team will encourage involvement of a parent or legal guardian when appropriate and safe. If there is concern for abuse, coercion, exploitation, or danger, the study team will follow applicable mandatory reporting laws and institutional policies, including notification of appropriate authorities and\u002For a parent or guardian when required to protect the participant or as otherwise required.\n\nEXCLUSION CRITERIA:\n\nExclusion criteria for patients include:\n\nAge less than 16.\n\nAdvanced stage of a pulmonary or a systemic illness in which the risk of the study is judged to be significant even in the absence of a clear contraindication to the procedures.\n\nExclusion criteria for patients for the formal exercise study and the stress echocardiogram include patients on continuous oxygen. Patients may perform an exercise test that will assess the patient's exercise capacity with activities of daily living.","ALL","16 Years","100 Years",{"count":62,"type":63},2000,"ESTIMATED","OBSERVATIONAL","Pulmonary lymphangioleiomyomatosis (LAM) is a destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor.\n\nThis study is designed to determine the disease processes involved at the level of cells and molecules, in order to develop more effective therapy.\n\nResearchers intend to identify the proteins and genes that contribute to the process of lung destruction in affected individuals.",[67,68,69,70],"Lung Disease","Pneumothorax","Tuberous Sclerosis","Lymphangioleiomyomatosis",[72,73,74,68,69,75],"Smooth Muscle Proliferation","Bronchoscopy","Female","Natural History","2026-08-19",{"date":78,"type":79},"2026-08-20","ACTUAL",{"date":81,"type":79},"1995-12-18",{"name":23,"class":6},1]