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NCT Number: NCT01468454

Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The 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 (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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants and children with a clinical diagnosis of hyperinsulinism who are suspected to have focal disease and are surgical candidates for pancreatectomy

Exclusion criteria

  • Pregnant or lactating females
  • Any other major illness or condition that might substantially increase the risk associated with the subject's participation in this study.

Treatment and study plan

18 F-DOPA

Drug

1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA

Other names: 18FDOPA PET SCAN

Primary outcomes

  1. Accuracy of 18F-DOPA PET/CT Scans to Detect Focal Lesions in Children With Congenital Hyperinsulinism

    Time frame: Surgery typically occured within a week post PET

    To determine the sensitivity and specificity of 18F-DOPA PET/CT for the detection of a focal pancreatic lesion in infants and children with poorly controlled hyperinsulinemic hypoglycemia.

Secondary outcomes

  1. Safety of 18F-DOPA PET/CT Scan - Number of Participants With Adverse Events

    Time frame: evaluated with 72 hours or prior to pancreatic surgery (if any)

    To further evaluate the safety of 18-labeled L-fluorodeoxyphenylalanine (18F-DOPA) PET/CT imaging in infants and children with congenital hyperinsulinism

    • subjects are monitored clinically for any signs or symptoms of adverse events for 72 hours post PET. Adverse events are documented and followed to resolution

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • University of Pennsylvania

Registry information

Official study title

A Phase II Safety and Efficacy Study of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Children With Hyperinsulinemic Hypoglycemia

Acronym: 18FDOPA

Important dates

Study start
2009
Primary completion
2014
Study completion
2018
First posted
Nov 9, 2011
Registry last updated
Oct 13, 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.

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