Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism - Full Text View

Sponsor:	Children's Hospital of Philadelphia
Collaborator:	University of Pennsylvania
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00674440

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	Phase II

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:

Genetics Home Reference related topics: familial hyperinsulinism

MedlinePlus related topics: Hypoglycemia Nuclear Scans

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 2011
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 may have PET imaging with F-DOPA prior to surgery.	Drug: F-DOPA 0.08-0.16 mCi/kg once Other Name: F-DOPA
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 Name: F-DOPA
Experimental: 2 Children diagnosed with hyperinsulinism who are successfully managed with diazoxide, octreotide, other medications,and/or tube feedings. Eligible children in this arm may have PET imaging with F-DOPA.	Drug: F-DOPA 0.08-0.16 mCi/kg once Other Name: F-DOPA

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 and for parents and caregivers of children with hyperinsulinism. This link exits the ClinicalTrials.gov site

Publications:

Hardy OT, Hernandez-Pampaloni M, Saffer JR, Scheuermann JS, Ernst LM, Freifelder R, Zhuang H, MacMullen C, Becker S, Adzick NS, Divgi C, Alavi A, Stanley CA. Accuracy of [18F]fluorodopa positron emission tomography for diagnosing and localizing focal congenital hyperinsulinism. J Clin Endocrinol Metab. 2007 Dec;92(12):4706-11. Epub 2007 Sep 25.

Hardy OT, Hernandez-Pampaloni M, Saffer JR, Suchi M, Ruchelli E, Zhuang H, Ganguly A, Freifelder R, Adzick NS, Alavi A, Stanley CA. Diagnosis and localization of focal congenital hyperinsulinism by 18F-fluorodopa PET scan. J Pediatr. 2007 Feb;150(2):140-5.

Hussain K, Seppänen M, Näntö-Salonen K, Adzick NS, Stanley CA, Thornton P, Minn H. The diagnosis of ectopic focal hyperinsulinism of infancy with [18F]-dopa positron emission tomography. J Clin Endocrinol Metab. 2006 Aug;91(8):2839-42. Epub 2006 May 9.

Hardy OT, Litman RS. Congenital hyperinsulinism - a review of the disorder and a discussion of the anesthesia management. Paediatr Anaesth. 2007 Jul;17(7):616-21. Review.

Otonkoski T, Näntö-Salonen K, Seppänen M, Veijola R, Huopio H, Hussain K, Tapanainen P, Eskola O, Parkkola R, Ekström K, Guiot Y, Rahier J, Laakso M, Rintala R, Nuutila P, Minn H. Noninvasive diagnosis of focal hyperinsulinism of infancy with [18F]-DOPA positron emission tomography. Diabetes. 2006 Jan;55(1):13-8.

Ribeiro MJ, Boddaert N, Delzescaux T, Valayannopoulos V, Bellanné-Chantelot C, Jaubert F, Verkarre V, Nihoul-Fékété C, Brunelle F, De Lonlay P. Functional imaging of the pancreas: the role of [18F]fluoro-L-DOPA PET in the diagnosis of hyperinsulinism of infancy. Endocr Dev. 2007;12:55-66.

Subramaniam RM, Karantanis D, Peller PJ. [18F]Fluoro-L-dopa PET/CT in congenital hyperinsulinism. J Comput Assist Tomogr. 2007 Sep-Oct;31(5):770-2.

Ribeiro MJ, Boddaert N, Bellanné-Chantelot C, Bourgeois S, Valayannopoulos V, Delzescaux T, Jaubert F, Nihoul-Fékété C, Brunelle F, De Lonlay P. The added value of [18F]fluoro-L-DOPA PET in the diagnosis of hyperinsulinism of infancy: a retrospective study involving 49 children. Eur J Nucl Med Mol Imaging. 2007 Dec;34(12):2120-8. Epub 2007 Jul 28.

de Lonlay P, Simon-Carre A, Ribeiro MJ, Boddaert N, Giurgea I, Laborde K, Bellanné-Chantelot C, Verkarre V, Polak M, Rahier J, Syrota A, Seidenwurm D, Nihoul-Fékété C, Robert JJ, Brunelle F, Jaubert F. Congenital hyperinsulinism: pancreatic [18F]fluoro-L-dihydroxyphenylalanine (DOPA) positron emission tomography and immunohistochemistry study of DOPA decarboxylase and insulin secretion. J Clin Endocrinol Metab. 2006 Mar;91(3):933-40. Epub 2006 Jan 10.

Responsible Party:	Chaitanya R. Divgi, MD, University of Pennsylvania
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:	July 6, 2011
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 February 09, 2012