Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
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:
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:
Radiation: PET scan
|
Outcome Measures
Primary Outcome Measures
- The ability of FDOPA PET to identify forms of hyperinsulinism that may be cured by surgery: focal forms. [one year]
Secondary Outcome Measures
- Assess safety of F-DOPA PET. [one year]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- The Congenital Hyperinsulinism Center at The Children's Hospital of Philadelphia
- International non-profit organization created by parents/families based in the United States
Publications
- 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.
- 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, 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.
- 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.
- 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.
- 04-003683
- FD-R-003457-01