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

NCT01916148 | Unknown

• 1 other identifier: 12-009528
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Congenital Hyperinsulinism (CHI); Beckwith-Wiedemann Syndrome; Insulinoma

Keywords

Hypoglycemia; Hyperinsulinism (HI); F-DOPA; PET; 18-F DOPA; 18F-L-Fluoro-DOPA; 18F-fluoro-L-dihydroxyphenylalanine; focal pancreatic lesions; congenital hyperinsulinism; Beckwith Wiedemann Syndrome; insulinoma; Hyperinsulinemic Hypoglycemia; F-DOPA PET; CHI (Congenital hyperinsulinism)

Interventions

18F-DOPA DRUG

18F-DOPA is a PET (Positron Emission Tomography) scan radiotracer.

Also known as: 18F-fluoro-L-dihydroxyphenylalanine, 18F-L-Fluoro-DOPA

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

AVAILABLE

Related Publications (10)

• https://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

  BACKGROUND

• https://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

  BACKGROUND

• States 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 BACKGROUND

• Sanders 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 8:1-15. doi: 10.1159/000550909. Online ahead of print.

  PMID: 41795819 BACKGROUND

• States 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 BACKGROUND

• 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.

  PMID: 35674212 BACKGROUND

• 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.

  PMID: 34336745 BACKGROUND

• 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.

  PMID: 30343978 BACKGROUND

• 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.

  PMID: 34230074 BACKGROUND

• 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.

  PMID: 32498990 BACKGROUND

Related Links

• Study description on CHOP research website
• CHOP HI Center program webpage

MeSH Terms

Conditions

Congenital Hyperinsulinism; Beckwith-Wiedemann Syndrome; Insulinoma; Hypoglycemia; Hyperinsulinism

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Adenoma, Islet Cell; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Officials

• Lisa States, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Becker, RN, BSN, CCRC

CONTACT

267-426-0269; Beckers@chop.edu

Lisa States, MD

CONTACT

267-425-7146; States@chop.edu

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 5, 2013
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)