Clinical trial · Expanded Access
18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
NCT01916148CI-TRIAL-00109517availableClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Beckwith-Wiedemann Syndrome | — | UNRESOLVED | — |
| Congenital Hyperinsulinism (CHI) | — | UNRESOLVED | — |
| Insulinoma | Pancreatic Insulinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-DOPA | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDhttps://jnm.snmjournals.org/content/63/supplement_2/2388 Abstract 2388 Authors: Nithya Navarathna, Deepa Dalal, Susan Becker and Lisa States Title: 18F-FDOPA PET imaging in Congenital Hyperinsulinism for localization of a Focal Pancreatic Lesion: Do medications interfere with radiotracer uptake? Journal of Nuclear Medicine Vol. 63, Issue supplement 2 August 1, 2022
- BACKGROUNDhttps://jnm.snmjournals.org/content/65/supplement_2/242379 Abstract 242379 Authors Eva Hamel, Lisa States and Susan Becker Title:18F-FDOPA PET/CT Imaging for Congenital Hyperinsulinism: What is the optimal imaging time? Journal of Nuclear Medicine Vol. 65, Issue supplement 2 June 1, 2024
- BACKGROUNDStates LJ, Becker SA, De Leon DD. Congenital hyperinsulinism: localization of a focal lesion with 18F-FDOPA positron emission tomography. Pediatr Radiol. 2022 Apr;52(4):693-701. doi: 10.1007/s00247-021-05206-5. Epub 2021 Oct 19. PMID 34668049
- BACKGROUNDSanders VR, Lord K, Sigal W, McKnight H, Wilkinson E, Mitteer LM, Boodhansingh KE, Adzick NS, States LJ, Bhatti TR, De Leon DD. Double Trouble: When Focal and Diffuse Hyperinsulinism Occur Simultaneously. Horm Res Paediatr. 2026 Mar 8:1-10. doi: 10.1159/000550909. Online ahead of print. PMID 41795819
- BACKGROUNDStates LJ, Francis P, Hamel ER, Becker SA, De Leon DD. Evaluation of Congenital Hyperinsulinism Using 18F-FDOPA PET. PET Clin. 2026 Apr;21(2):321-330. doi: 10.1016/j.cpet.2025.11.001. Epub 2026 Jan 14. PMID 41539914
- BACKGROUNDBoodhansingh 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. PMID 35674212
- BACKGROUNDRosenfeld 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.