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

Launched by MIGUEL PAMPALONI · Dec 17, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a special type of imaging called FDOPA/PET to help doctors find and understand a condition known as congenital hyperinsulinism, which causes the body to produce too much insulin, leading to low blood sugar. The main goal is to see if this imaging can help differentiate between two forms of the condition—focal (where the problem is in a specific area of the pancreas) and diffuse (where the problem is widespread)—and to locate the exact spots in the pancreas that might need surgery.

The trial is open to participants of all ages, but it focuses primarily on infants under 6 months old, as this is when the condition often first appears. To be eligible, children should have a diagnosis of either focal or diffuse congenital hyperinsulinism, confirmed by specific tests, and they must be experiencing low blood sugar that is not controlled by current treatments. Participants will undergo a PET scan, and it’s important that they can stop certain medications beforehand. This trial could provide useful information that helps guide treatment decisions for children with this challenging condition.

Gender

ALL

Eligibility criteria

• 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.