[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Miguel Pampaloni\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Congenital Hyperinsulinism","RECRUITING","2026-04-27",{"date":32,"type":33},"2026-05-01","ACTUAL",{"date":35,"type":33},"2016-11-03",{"date":37,"type":22},"2026-12-01",{"name":39,"class":40},"Miguel Pampaloni","OTHER",""]