| May 5, 2008 |
| January 25, 2009 |
| December 2004 |
| December 2008 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00674440 on ClinicalTrials.gov Archive Site |
| Assess safety of F-DOPA PET. [ Time Frame: one year ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism |
| Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-Labeled L-Fluoro-DOPA PET Scan |
Children with congenital hyperinsulinism 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 PET scans with F-DOPA prior to surgery. |
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. |
| Phase II |
| Interventional |
| Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
- Congenital Hyperinsulinism
- Hyperinsulinism
- Persistent Hyperinsulinemic Hypoglycemia of Infancy
- CHI
- PHHI
|
| Drug: F-DOPA |
- Experimental: 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.
- Experimental: 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.
- Experimental: 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.
|
- 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.
|
| |
| Active, not recruiting |
| 100 |
| June 2009 |
| December 2008 (final data collection date for primary outcome measure) |
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.
|
| Both |
| up to 18 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00674440 |
| Chaitanya R. Divgi, MD, University of Pennsylvania |
| 802337, 2004-3-3683, FD-R-003457-01 |
| University of Pennsylvania |
|
| Principal Investigator: |
Chaitanya R. Divgi, MD |
University of Pennsylvania |
|
|
| University of Pennsylvania |
| January 2009 |
