Clinical Trial: Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-labeled L-fluoro-DOPA PET Scan

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: The ability of FDOPA PET to identify forms of hyperinsulinism that may be cured by surgery: focal forms. [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Assess safety of F-DOPA PET. [ Time Frame: one year ]

Original Secondary Outcome: Same as current

Information By: Children's Hospital of Philadelphia

Dates:
Date Received: May 5, 2008
Date Started: December 2004
Date Completion: December 2017
Last Updated: January 31, 2017
Last Verified: January 2017