Actively Recruiting
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
Led by Cook Children's Health Care System · Updated on 2024-07-16
250
Participants Needed
1
Research Sites
764 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with congenital hyperinsulinism attending the Cook Children's Congenital Hyperinsulinism Center under an endocrinologist
- Patients whose doctors have determined that standard medical treatment has failed and surgery is recommended to prevent severe low blood sugar and protect brain function
- Failure of medical therapy defined as low blood sugar below 70 mg/dL despite anti-hypoglycemic drugs and inability to fast with safe blood sugar levels for specific durations based on age
- Patients without genetic evidence of diffuse congenital hyperinsulinism, including those with no genetic test results or negative results
- Patients with suspected focal congenital hyperinsulinism or insulinoma who have well-controlled blood sugar but wish to proceed with surgery for a possible cure
You will not qualify if you...
- Patients without a diagnosis of congenital hyperinsulinism
- Patients with genetic evidence of diffuse congenital hyperinsulinism
- Pregnant patients
- Nursing mothers unwilling to stop breastfeeding for 48 hours after Fluorodopa F 18 injection
- Patients allergic to Fluorodopa F 18
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
Research Team
D
Deborah Rafferty, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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