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 Protocol dated 07/23/09.
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- STATUS
- None
Summary
The purpose of this research study is to 18F-DOPA is used in a nuclear medicine test. This test is called an F-DOPA PET scan and has been successfully at The Children's Hospital of Philadelphia (CHOP) since 2004, and in Europe, on more than 120 subjects with hyperinsulinism to identify focal lesions. Because 18F-DOPA has not yet been approved by the Food and Drug Administration (FDA), we can only do this test as part of a research study. The Department of Radiology at the University of Pennsylvania School of Medicine holds the IND license for this tracer. Therefore the purpose of the current study is to be able to offer this important diagnostic test to patients with hyperinsulinism until the FDA grants approval for the routine use of 18F-DOPA. The results of the test will made be available to your physicians and may be used by the surgeon if your child has an operation.
Details
| Condition | TBD, tbd, tbd |
|---|---|
| Age | 99years or below |
| Clinical Study Identifier | TBD |
| Last Modified on | 19 February 2024 |
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