RecruitingPhase 2NCT04205604
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
Sponsor
Miguel Pampaloni
Enrollment
50 participants
Start Date
Nov 3, 2016
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 0 DaysMax Age: 18 Years
Inclusion Criteria7
- 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 Criteria2
- Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).
- Patients with hepatic or renal insufficiency.
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Interventions
DRUG18F-Fluoro Dopa Imaging
Imaging with 18F-Fluoro Dopa PET Imaging
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04205604