RecruitingPhase 1NCT02021604

Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma

The Use of Fluorodopa F 18 Positron Emission Tomography Combined With Computed Tomography in Congenital Hyperinsulinism and Insulinoma

Sponsor

Cook Children's Health Care System

Enrollment

250 participants

Start Date

Oct 9, 2013

Study Type

INTERVENTIONAL

Conditions

Congenital Hyperinsulinism Insulinoma

Summary

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.

Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a specialized radioactive imaging scan (called fluorodopa F-18 PET) to help identify the exact area of the pancreas causing dangerous low blood sugar in babies and children with a condition called congenital hyperinsulinism, as well as in adults with insulin-producing tumors (insulinomas). **You may be eligible if...** - You are a child with congenital hyperinsulinism (a condition where the pancreas produces too much insulin, causing very low blood sugar) and have not responded to medication - You are an adult or child with a suspected insulinoma (a small insulin-producing tumor of the pancreas) - Surgery is being considered and doctors need to pinpoint the exact location of the problem - You or your parent/guardian can give informed consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are unable to remain still for the imaging scan (sedation can be used for young children in some cases) - You have kidney problems that prevent safe use of the radioactive imaging agent - You have already had the relevant surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluorodopa F 18

A dose of Fluorodopa F 18, 3-6 MBq/Kg (0.08-0.16 mCi/kg), will be injected intravenously into the subject under the direct supervision of the radiology sub-investigator. Then, the PET imaging procedure will begin and proceed for up to 70 minutes after injection. An abdominal CT image will be made using intravenous contrast. Both images, PET and CT, will be co-localized by the radiologist for interpretation.