NCT04205604 · Miguel Pampaloni
18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
(DOPA PET)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
18F-Fluoro Dopa Imaging
Imaging with 18F-Fluoro Dopa PET Imaging
Primary outcome measures
Sensitivity of Imaging
Time frame: four weeks
To determine the sensitivity and specificity of FDOPA PET/CT in differentiating focal and diffuse forms of HI in infants with medically refractory hypoglycemia
Accuracy of Imaging
Time frame: four weeks
To determine the accuracy of FDOPA PET/CT localizing areas of islet cell adenomatosis within the pancreas in patients with focal HI, by identifying the area of abnormal uptake of the raioligand
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- San Francisco, California
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Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations