Phase II Safety and Efficacy Study of F-DOPA PET/CT in Children With Hyperinsulinemic Hypoglycemia
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/21/2018 |
| Start Date: | January 2009 |
| End Date: | February 2018 |
A Phase II Safety and Efficacy Study of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Children With Hyperinsulinemic Hypoglycemia
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these
children may require surgery to remove part or all of their pancreas. In this study,
researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine
(called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery.
Eligible participants in this study will have positron emission tomography/computerized
tomography (PET/CT) scans with F-DOPA prior to surgery.
children may require surgery to remove part or all of their pancreas. In this study,
researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine
(called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery.
Eligible participants in this study will have positron emission tomography/computerized
tomography (PET/CT) 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 (called diffuse disease); others have them located in specific areas of the
pancreas (called focal disease). Children who have focal disease located in specific areas of
the pancreas may be cured with surgery. F-DOPA is a radioactive drug that is picked up by
these cells and used for positron emission tomography (or PET), an imaging technique used in
nuclear medicine departments. In this study, researchers will validate the efficacy and
safety of using PET/CT with F-DOPA in the pre-operative localization of focal disease in
children with hyperinsulinism.
pancreas that release too much insulin. Some children with CHI have these cells throughout
their pancreas (called diffuse disease); others have them located in specific areas of the
pancreas (called focal disease). Children who have focal disease located in specific areas of
the pancreas may be cured with surgery. F-DOPA is a radioactive drug that is picked up by
these cells and used for positron emission tomography (or PET), an imaging technique used in
nuclear medicine departments. In this study, researchers will validate the efficacy and
safety of using PET/CT with F-DOPA in the pre-operative localization of focal disease in
children with hyperinsulinism.
Inclusion Criteria:
- Infants and children with a clinical diagnosis of hyperinsulinism who are suspected to
have focal disease and are surgical candidates for pancreatectomy
Exclusion Criteria:
- Pregnant or lactating females
- Any other major illness or condition that might substantially increase the risk
associated with the subject's participation in this study.
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