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18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
RecruitingPhase 2
18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
Who can join
0 Days – 18 Years · All sexes
Full eligibility criteria
Inclusion Criteria: * Any age, but primarily infants 0-6 months given typical age of initial presentation. * 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) o confirmed by genetic testing for mutations in ABCC8 and KCNJ1 was1. * Hypoglycemia uncontrolled with medical management (diazoxide, octreotide). * Able to withdraw medications in time to wash out prior to the scheduled PET scan. * Patients fulfilling criteria above but with uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy) * Normal hepatic and renal function. Exclusion Criteria: * Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon). * Patients with hepatic or renal insufficiency.
About the study
The goal of this project is to determine the role of FDOPA/PET 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.
What is being tested
- 18F-Fluoro Dopa Imaging (drug)
Sponsor: Miguel Pampaloni · Participants: 50 · Started: Nov 3, 2016
Contact the study team
Official record on ClinicalTrials.gov — NCT04205604
Locations in the U.S.
| California | University of California, San Francisco, San Francisco |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.