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18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism

RecruitingPhase 2Ages 0 Days - 18 YearsAllMiguel Pampaloni
NCT04205604 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • 18F-Fluoro Dopa Imaging
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Where

1 site
University of California, San Francisco
San Francisco, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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