[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"congenital-hyperinsulinism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:congenital-hyperinsulinism":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,68],{"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":41},"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",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":41},"100416764","phase-3-18f-dopa-ii---pet-imaging-optimization-100416764","NCT04706910","18F-DOPA II - PET Imaging Optimization","Inclusion Criteria:\n\n1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism.\n2. Pediatric patients (less than 18 years old) with neuroblastoma.\n3. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor.\n4. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia.\n5. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors.\n\nExclusion Criteria:\n\n1. Unable to obtain consent\n2. Weight \\>225 kg (weight limitation of PET\u002FCT scanner)\n3. Adult patients unable to lie flat for 20-30 minutes to complete the PET-CT session.\n4. Young pediatric patients (less than 13 years old) who are unable to lie flat for 20-30 minutes and for whom clinical sedation is contraindicated (as determined by a pediatric anaesthesiologist).\n5. Lack of intravenous access\n6. History of previous cholecystectomy (excluded from dynamic abdomen sub-study only)\n7. Pregnancy",{"count":49,"type":22},800,[51],"PHASE3","A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET\u002FCT imaging in specific patient populations:\n\n1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism.\n2. Pediatric patients (less than 18 years old) with neuroblastoma.\n3. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor.\n4. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia.\n5. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors.\n\nImage optimization (the primary study objective) and gallbladder activity pattern (the secondary objective) will be evaluated.",[28,54,55,56,57,58],"Neuroblastoma","Parkinson Disease","Lewy Body Disease","Neuroendocrine Tumors","Brain Tumor","2026-02-04",{"date":61,"type":33},"2026-02-09",{"date":63,"type":33},"2021-01-20",{"date":65,"type":22},"2027-12",{"name":67,"class":40},"University of Alberta",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":19,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":41},"100210840","phase-1-fluorodopa-f-18-in-congenital-hyperinsulinism-and-insulinoma-100210840","NCT02021604","Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma","The Use of Fluorodopa F 18 Positron Emission Tomography Combined With Computed Tomography in Congenital Hyperinsulinism and Insulinoma","Inclusion Criteria:\n\n* Patients with HI attending the Cook Children's Congenital Hyperinsulinism Center and being treated by an Endocrinologist which may be the PI or a partner of this clinician.\n* The 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. Failure of medical therapy is defined as both:\n\n  * Hypoglycemia (blood glucose \\\u003C70 m\u002FdL) on a single measure despite the use of anti-hypoglycemic medications, if applicable to the individual patient, including and limited to diazoxide or octreotide\n  * Inability to fast, defined as the inability to maintain a blood glucose \\>50 mg\u002FdL for: 1) more than 12 hours for infants \\\u003C 1 year of age; 2) more than 15 hours 1-3 years of age; 3) more than 18 hours over 3 years of age\n* Patients in whom the genetic testing (if available and informative) does not prove diffuse HI disease. Such children might be considered if they have one or more of the following situations:\n\n  * no genetic testing results (e.g., due to insurance denial or parental refusal)\n  * negative genetic testing (note: only 75% of mutations may be found with existing technology)\n  * no autosomal recessive mutations in ABCC8 or KCNJ11 on the maternal allele\n  * no autosomal dominant mutations in ABCC8 or KCNJ11\n* Patients thought to have focal HI disease based on genetic testing or insulinoma based on clinical evaluation and have well-controlled blood glucose levels with any degree of dietary or medical management, BUT the patient and their parent(s) or LAR wishes to proceed with surgery for a possible cure of HI disease.\n\nExclusion Criteria:\n\n* Patients who do not have a diagnosis of HI\n* Patients with genetic evidence of diffuse HI\n* Patients who are pregnant\n* Nursing mothers who are unwilling to discontinue breastfeeding their infant for 48 hours after Fluorodopa F 18 injection\n* Patients with a known allergy to Fluorodopa F 18 agent",{"count":76,"type":22},250,[78],"PHASE1","Low blood sugars are known to cause brain damage in newborn babies. One of the most common causes of low blood sugars persisting beyond the new born period is a condition called congenital hyperinsulinism (HI). This is a disease whereby the pancreas secretes too much insulin and causes low blood sugars. Twenty to forty percent of these babies will have brain damage. There are two forms of this disease. In one form only a small part of the pancreas makes too much insulin (focal HI) and in the other, the whole pancreas make too much insulin (diffuse HI). Another very similar disease is insulinoma which occurs after birth, but also causes hyperinsulinism. If a surgeon could know which part of the pancreas has the focal lesion he could remove it and cure the patient.\n\nThe purpose of this study is to investigate whether a new investigational drug called Fluorodopa F 18, when used with a PET scan, can find the focal lesion and guide the surgeon to remove it, thus curing the patient and preventing further brain damage.",[28,81],"Insulinoma",[28,83,84,85,86,87,81],"HI","Hypoglycemia","FDOPA","18F-DOPA","Hyperinsulinism","2024-07-15",{"date":90,"type":33},"2024-07-16",{"date":92,"type":33},"2013-10-09",{"date":94,"type":22},"2028-06",{"name":96,"class":40},"Cook Children's Health Care System"]