Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma

Low blood sugars are known to cause brain damage in newborn babies. One of the most common causes of low blood sugars persisting beyond the new born period is a condition called congenital hyperinsulinism (HI). This is a disease whereby the pancreas secretes too much insulin and causes low blood sugars. Twenty to forty percent of these babies will have brain damage. There are two forms of this disease. In one form only a small part of the pancreas makes too much insulin (focal HI) and in the other, the whole pancreas make too much insulin (diffuse HI). Another very similar disease is insulinoma which occurs after birth, but also causes hyperinsulinism. If a surgeon could know which part of the pancreas has the focal lesion he could remove it and cure the patient. The purpose of this study is to investigate whether a new investigational drug called Fluorodopa F 18, when used with a PET scan, can find the focal lesion and guide the surgeon to remove it, thus curing the patient and preventing further brain damage.

NCT Number	NCT02021604
Lead Sponsor	Cook Children's Health Care System
Conditions	Congenital Hyperinsulinism, Insulinoma
Enrollment	250 participants
Start Date	2013-10-09
Primary Completion	2028-01 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2024-07-16