Insulinoma Clinical Trial
Official title:
Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
| NCT number | NCT01916148 |
| Other study ID # | 12-009528 |
| Secondary ID | |
| Status | Available |
| Phase | |
| First received | |
| Last updated |
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.
| Status | Available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital of Philadelphia |
United States,
Adzick NS, De Leon DD, States LJ, Lord K, Bhatti TR, Becker SA, Stanley CA. Surgical treatment of congenital hyperinsulinism: Results from 500 pancreatectomies in neonates and children. J Pediatr Surg. 2019 Jan;54(1):27-32. doi: 10.1016/j.jpedsurg.2018.10.030. Epub 2018 Oct 5. — View Citation
Boodhansingh KE, Yang Z, Li C, Chen P, Lord K, Becker SA, States LJ, Adzick NS, Bhatti T, Shyng SL, Ganguly A, Stanley CA, De Leon DD. Localized islet nuclear enlargement hyperinsulinism (LINE-HI) due to ABCC8 and GCK mosaic mutations. Eur J Endocrinol. 2022 Jun 27;187(2):301-313. doi: 10.1530/EJE-21-1095. Print 2022 Aug 1. — View Citation
Rosenfeld E, Mitteer L, Boodhansingh K, Becker SA, McKnight H, Boyajian L, Ackermann AM, Kalish JM, Bhatti TR, States LJ, Adzick NS, Lord K, De Leon DD. Case Report: Two Distinct Focal Congenital Hyperinsulinism Lesions Resulting From Separate Genetic Events. Front Pediatr. 2021 Jul 16;9:699129. doi: 10.3389/fped.2021.699129. eCollection 2021. — View Citation
States LJ, Davis JC, Hamel SM, Becker SA, Zhuang H. 18F-6-Fluoro-l-Dopa PET/CT Imaging of Congenital Hyperinsulinism. J Nucl Med. 2021 Jul;62(Suppl 2):51S-56S. doi: 10.2967/jnumed.120.246033. — View Citation
States LJ, Saade-Lemus S, De Leon DD. 18-F-L 3,4-Dihydroxyphenylalanine PET/Computed Tomography in the Management of Congenital Hyperinsulinism. PET Clin. 2020 Jul;15(3):349-359. doi: 10.1016/j.cpet.2020.03.004. — View Citation
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