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Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Charles Stanley, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00674440
First received: May 5, 2008
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Congenital Hyperinsulinism
Hyperinsulinism
Persistent Hyperinsulinemic Hypoglycemia of Infancy
CHI
PHHI
 Drug: F-DOPA
Radiation: PET scan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-labeled L-fluoro-DOPA PET Scan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • The ability of FDOPA PET to identify forms of hyperinsulinism that may be cured by surgery: focal forms. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess safety of F-DOPA PET. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 105
Study Start Date: December 2004
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and will be scheduled for surgery. Eligible children in this arm will PET imaging with F-DOPA prior to surgery.
 Drug: F-DOPA
0.08-0.16 mCi/kg once
Other Names:
  • 18F-labeled L-fluorodeoxyphenylalanine
  • 18F-DOPA
Radiation: PET scan
Experimental: 3
Children diagnosed with hyperinsulinism who have had partial pancreas removal but still display signs of hyperinsulinism. Eligible children in this arm may have PET imaging with F-DOPA.
 Drug: F-DOPA
0.08-0.16 mCi/kg once
Other Names:
  • 18F-labeled L-fluorodeoxyphenylalanine
  • 18F-DOPA
Radiation: PET scan
Experimental: 2
Children diagnosed with hyperinsulinism who are successfully managed with diazoxide, octreotide, other medications,and/or tube feedings. Eligible children in this arm will PET imaging with F-DOPA.
 Drug: F-DOPA
0.08-0.16 mCi/kg once
Other Names:
  • 18F-labeled L-fluorodeoxyphenylalanine
  • 18F-DOPA
Radiation: PET scan

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; 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00674440

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Investigators
Principal Investigator: Chaitanya R. Divgi, MD University of Pennsylvania
  More Information

Additional Information:
The Children's Hyperinsulinism Fund helps children in the UK and around the world who suffer from Congenital Hyperinsulinism.  This link exits the ClinicalTrials.gov site
This website is produced by parents in the UK for parents and caregivers of children with hyperinsulinism.  This link exits the ClinicalTrials.gov site
International non-profit organization created by parents/families based in the United States  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Charles Stanley, Attending Physician, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00674440     History of Changes
Other Study ID Numbers: 802337, 2004-3-3683, FD-R-003457-01
Study First Received: May 5, 2008
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Congenital Hyperinsulinism
Hyperinsulinism
Persistent Hyperinsulinemic Hypoglycemia of Infancy
CHI
 PHHI
F-DOPA
L-fluoro-dihydroxyphenylalanine

Additional relevant MeSH terms:
Hyperinsulinism
Hypoglycemia
Nesidioblastosis
Persistent Hyperinsulinemia Hypoglycemia of Infancy
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
 Infant, Newborn, Diseases
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013