Conditions: Congenital Hyperinsulinism (CHI) Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
Keywords: Congenital Hyperinsulinism (CHI) hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI) CHI PHHI Pancreatectomy 18F-DOPA PET/CT scan
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 130
Healthy volunteers: no

Brief summary:
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas. In this study, researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery. Eligible participants in this study will have positron emission tomography/computerized tomography (PET/CT) scans with F-DOPA prior to surgery.

Detailed description:
For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas (called diffuse disease); others have them located in specific areas of the pancreas (called focal disease). Children who have focal disease located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that is picked up by these cells and used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will validate the efficacy and safety of using PET/CT with F-DOPA in the pre-operative localization of focal disease in children with hyperinsulinism.

Arms:
arm 1: Obtain safety and efficacy data on the use of 18-labeled L-fluorodeoxyphenylalanine (18F-DOPA) PET imaging in children with HI for the clinical indication of localizing a focal lesion

Interventions: intervention 1: 18 F-DOPA
Intervention descriptions: intervention 1: 1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA

Protocol document: