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Study identifier: NCT02021604 Synced from ClinicalTrials.gov · July 28, 2026
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Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma

Condition: Congenital Hyperinsulinism · Insulinoma  ·  Sponsor: Cook Children's Health Care System

PhasePhase 1
Planned participants250
Who can joinAll sexes, N/A to 18 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Deborah Rafferty, PhD  ·  682-303-1363  ·  Deborah.Rafferty@cookchildrens.org

Always discuss trial participation with your own doctor first.

Locations (1)

Cook Children's Medical CenterFort Worth, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT02021604