Skip to main content
OpenTrials
Completed

NCT Number: NCT00674440

Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Hyperinsulinism CHI Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Infant, Newborn, Diseases Metabolic Diseases Nutritional and Metabolic Diseases PHHI Pancreatic Diseases Persistent Hyperinsulinemic Hypoglycemia of Infancy

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

F-DOPA

Drug

0.08-0.16 mCi/kg once

Other names: 18F-labeled L-fluorodeoxyphenylalanine, 18F-DOPA

PET Scan

Radiation

Primary outcomes

  1. The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism

    Time frame: up to 1 month post surgical intervention

    Comparison of PET scan results with outcome of surgery and histopathology results confirmed as focal or diffuse

Secondary outcomes

  1. Safety of F-DOPA PET

    Time frame: 72 hours maximum or prior to pancreatic surgery

    Number of Participants with Adverse Events

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
May 7, 2008
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.