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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):
Lisa States, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00674440
First received: May 5, 2008
Last updated: January 31, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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:


Further study details as provided by Lisa States, 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 ]

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

Enrollment: 105
Study Start Date: December 2004
Estimated Study Completion Date: December 2017
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   (Child, Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Investigators
Principal Investigator: Lisa J States, MD Children's Hospital of Philadelphia
  More Information

Additional Information:
Publications:

Responsible Party: Lisa States, Attending Physician/Radiologist, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00674440     History of Changes
Other Study ID Numbers: 04-003683
FD-R-003457-01 ( Other Grant/Funding Number: FDA orphan drug grant )
Study First Received: May 5, 2008
Last Updated: January 31, 2017

Keywords provided by Lisa States, 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
Congenital Hyperinsulinism
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017