18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism (NCT04205604) | Clinical Trial Compass
RecruitingPhase 2
18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
United States50 participantsStarted 2016-11-03
Plain-language summary
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.
Who can participate
Age range0 Days – 18 Years
SexALL
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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.