[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446081":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":33,"maxAge":33,"enrollmentInfo":74,"targetDuration":33,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":41,"whyStopped":33,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"18F-Fluoro Dopa Imaging","EXPERIMENTAL","single arm",[13],"Drug: 18F-Fluoro Dopa PET\u002FMRI Imaging",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","18F-Fluoro Dopa PET\u002FMRI Imaging","The purpose of this research study is to provide access to an imaging study of the pancreas that uses 6-\\[18F\\]-Fluoro-L-3,4,-dihydroxyphenylalanine (18F-DOPA)positron emission tomography (PET) and assess the accuracy of this 18F-DOPA-PET\u002FMRI test on distinguishing what part of the pancreas is affected in patients with Hyperinsulinism.",[9],[21,22,23],"6-[18F]-Fluoro-L-3,4,-dihydroxyphenylalanine","18F-DOPA","[18F]-Fluorodopa",[25],{"name":26,"affiliation":5,"role":27},"Ana Maria Arbelaez, MD, MSCI","PRINCIPAL_INVESTIGATOR",[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Pamela S Stone, RN","CONTACT","314-747-4659",null,"stone.p@wustl.edu",{"name":26,"role":31,"phone":36,"phoneExt":33,"email":37},"314-286-1138","aarbelaez@wustl.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Washington University","RECRUITING","St Louis","Missouri","63110","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-90.19789,38.62727,{"lat":51,"lon":50},[54,57],{"name":55,"role":31,"phone":56,"phoneExt":33,"email":37},"Ana M Arbelaez, MD","314-454-6051",{"name":58,"role":59,"phone":33,"phoneExt":33,"email":33},"Maria R Ponisio, MD","SUB_INVESTIGATOR",{"type":61,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[63],{"name":64,"class":6},"St. Louis Children's Hospital","100446081","phase-2-utility-of-18fdopa-petmri-for-focal-hyperinsulinism-100446081",false,"NCT05088798","Utility of 18FDOPA PET\u002FMRI for Focal Hyperinsulinism","Use of18F-DOPA PET\u002FMRI for the Detection and Localization of Focal Forms of Hyperinsulinism","18FDOPA HI","Inclusion Criteria:\n\n1. Patients with confirmed hyperinsulinemic hypoglycemia, diagnosed by elevated insulin levels during hypoglycemia and\u002For response to glucagon stimulation.\n2. Subjects who failed pharmacological therapy with diazoxide or octreotide.\n3. Subjects with signed informed consent by themselves or their parents or legal guardians.\n4. Patient's Endocrinologist has determined that the patient cannot be safely managed with standard medical therapy (failed) and surgery is recommended to prevent future episodes of severe hypoglycemia and preserve brain function.\n\nExclusion Criteria:\n\n1. Any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study.\n2. Patient must not have any contraindication to MRI as evaluated by a standardized MRI safety questionnaire. If MRI is contraindicated, and patient meets inclusion criteria and has no other contraindications study will be conducted in PET\u002FCT scanner.\n3. Cases in which surgery will not be considered by parents or guardians.","ALL",{"count":75,"type":76},100,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","The purpose of the study is to provide access to 18F-DOPA PET to patients at Washington University and assess the utility of 18F-DOPA PET\u002FMRI as a preoperative tool to detect and localize focal lesions in the pancreas that are causing hyperinsulinism.",[82],"Hyperinsulinism",[84,85,86,82,87],"hypoglycemia","Glucose Metabolism Disorders","Infant, Newborn, Diseases","Insulinoma","2025-12-17",{"date":90,"type":91},"2025-12-19","ACTUAL",{"date":93,"type":91},"2020-09-10",{"date":95,"type":76},"2030-01-01",{"name":5,"class":6},1]