Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Phase 2

Conditions: Hyperinsulinism; PHHI; CHI; Congenital Hyperinsulinism; Persistent Hyperinsulinemic Hypoglycemia of Infancy

Treatments: Radiation: PET scan; Drug: F-DOPA

Study type: Interventional

Funder types: Other

Identifiers

NCT00674440

FD-R-003457-01 (Other Grant/Funding Number)

04-003683

Details and patient eligibility

About

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.

Full 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; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.

Enrollment: 106 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any age, but primarily infants 0-6 months.
• Children with confirmed diagnosis of congenital hyperinsulinism.

Exclusion criteria

• Cases in which surgery will not be considered by parents or guardians.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Subjects who had PET and surgery

Experimental group

Description:

Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and are candidates to be scheduled for surgery for partial pancreatectomy. Eligible children will undergo PET imaging with F-DOPA prior to surgery.

Treatment:

Radiation: PET scan

Drug: F-DOPA