Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia

12-009528

This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET (Positron Emission Tomography) scan to detect a focal lesion of hyperinsulinism and determine the location in patients with congenital hyperinsulinism, Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.

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Inclusion Criteria: * Subjects of any age with hyperinsulinemic hypoglycemia, diagnosed by a fasting test and/or response to glucagon stimulation. * Subjects who are eligible for pancreatic surgery regardless of prior pancreatic surgery Exclusion Criteria: * Pregnant or lactating females * Any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study * Subjects who are not a candidate for pancreatic surgery

{'studyType': 'EXPANDED_ACCESS'}

2024-04-04