Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

Hyperinsulinism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674440
• Other study ID #: 04-003683
• Secondary ID: FD-R-003457-01
• Status: Completed
• Phase: Phase 2
• Start date: December 2004
• Est. completion date: January 2009

Study information

• Verified date: October 2022
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• CHI
• Congenital Hyperinsulinism
• Hyperinsulinism
• Hypoglycemia
• Nesidioblastosis
• Persistent Hyperinsulinemic Hypoglycemia of Infancy
• PHHI

Intervention

Drug:
• F-DOPA
0.08-0.16 mCi/kg once

Radiation:
• PET scan

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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 cong — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ribeiro MJ, Boddaert N, Delzescaux T, Valayannopoulos V, Bellanné-Chantelot C, Jaubert F, Verkarre V, Nihoul-Fékété C, Brunelle F, 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. doi: 10.1159/000109605. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism	Comparison of PET scan results with outcome of surgery and histopathology results confirmed as focal or diffuse	up to 1 month post surgical intervention
Secondary	Safety of F-DOPA PET	Number of Participants with Adverse Events	72 hours maximum or prior to pancreatic surgery

External Links

•   International non-profit organization created by parents/families based in the United States
•   The Congenital Hyperinsulinism Center at The Children's Hospital of Philadelphia