18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
ConditionCongenital Hyperinsulinism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age0-18
SponsorMiguel Pampaloni
About this trial
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.
Eligibility criteria
Qualifiers
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)
Hypoglycemia uncontrolled with medical management (diazoxide, octreotide).
Able to withdraw medications in time to wash out prior to the scheduled PET scan.
Disqualifiers
Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).
Patients with hepatic or renal insufficiency.
Trial design
Treatments tested in this trial
- 18F-Fluoro Dopa Imaging
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Miguel Pampaloni
Lead sponsor
University of California, San Francisco
Sponsor institution
Source ClinicalTrials.gov