[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100378288":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":25,"responsibleParty":43,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":20,"overallStatus":27,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm,","EXPERIMENTAL","Patients with clinically diagnosed congenital hyperinsulinism",[13],"Drug: 18F-Fluoro Dopa Imaging",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","18F-Fluoro Dopa Imaging","Imaging with 18F-Fluoro Dopa PET Imaging",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Miguel Hernandez Pampaloni, MD, PhD","PRINCIPAL_INVESTIGATOR",[26],{"facility":5,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","San Francisco","California","94143","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-122.41942,37.77493,{"lat":37,"lon":36},[40],{"name":23,"role":41,"phone":42,"phoneExt":20,"email":20},"CONTACT","415-353-1886",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Miguel Pampaloni","Associate Professor of Radiology & Medicine","100378288","phase-2-18fluoroldopa-pet-imaging-for-the-detection-and-localization-of-focal-congenital-hyperinsulinism-100378288",false,"NCT04205604","18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism","18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism","DOPA PET","Inclusion Criteria:\n\n* Any age, but primarily infants 0-6 months given typical age of initial presentation.\n* Children with diagnosis of FoHI or DiHI based on clinical criteria (fasting hypoglycemia accompanied by inadequate suppression of plasma insulin, inappropriately low plasma free fatty acid and plasma-hydroxybutyrate concentrations, and an inappropriate glycemic response to glucagon injection)\n\n  o confirmed by genetic testing for mutations in ABCC8 and KCNJ1 was1.\n* Hypoglycemia uncontrolled with medical management (diazoxide, octreotide).\n* Able to withdraw medications in time to wash out prior to the scheduled PET scan.\n* Patients fulfilling criteria above but with uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy)\n* Normal hepatic and renal function.\n\nExclusion Criteria:\n\n* Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).\n* Patients with hepatic or renal insufficiency.","ALL","0 Days","18 Years",{"count":59,"type":60},50,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","The goal of this project is to determine the role of FDOPA\u002FPET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas to guide surgical resection.",[66],"Congenital Hyperinsulinism","2026-04-27",{"date":69,"type":70},"2026-05-01","ACTUAL",{"date":72,"type":70},"2016-11-03",{"date":74,"type":60},"2026-12-01",{"name":45,"class":6},1]