ClinicalTrials.gg
Sign In
AvailableNCT01916148Updated Apr 27, 2026

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

An expanded access record providing 18F-DOPA in Congenital Hyperinsulinism (CHI), Beckwith-Wiedemann Syndrome and Insulinoma, sponsored by Children's Hospital of Philadelphia. Available at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by Children's Hospital of Philadelphia · Expanded access

Study type
Expanded access
Access type
Intermediate-size population
Sex
All
01

Study 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.

Read the detailed description

Patients with hyperinsulinemic hypoglycemia are at risk for neurological damage due to hypoglycemia. Early surgical intervention can be preventative. F-DOPA PET may be able to detect of a focal lesion prior to surgical intervention and be used during surgical planning to guide the surgical procedure.

02

Conditions studied

  • 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)
03

In context

Congenital Hyperinsulinism

38 studies on the registry are indexed under Congenital Hyperinsulinism; 6 are open to participants now.

Browse Congenital Hyperinsulinism studies →

Lead sponsor

Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.

Browse Children's Hospital of Philadelphia studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • Drug18F-DOPA

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

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

06

Where to request access

1 of 1 sites recruiting
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
    Available
    • Lisa States, MD · Principal investigator
07

References and documents

Publications

  • 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
  • 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
  • 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. PubMed 34668049 ↗
  • 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 8:1-10. doi: 10.1159/000550909. Online ahead of print. PubMed 41795819 ↗
  • 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. PubMed 41539914 ↗
  • 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. PubMed 35674212 ↗
  • 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. PubMed 34336745 ↗
  • 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. PubMed 30343978 ↗
  • 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. PubMed 34230074 ↗
  • 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. PubMed 32498990 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01916148
Lead sponsor
Children's Hospital of Philadelphia
Responsible party
Lisa States (Principal Investigator, Children's Hospital of Philadelphia) — Principal investigator
First posted
Aug 5, 2013
Last update
Apr 27, 2026

Study contacts

Susan Becker, RN, BSN, CCRC
Contact
Beckers@chop.edu
267-426-0269
Lisa States, MD
Contact
States@chop.edu
267-425-7146
Lisa States, MD
principal investigator · Children's Hospital of Philadelphia
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

Contact the provider

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Congenital Hyperinsulinism →

Other studies from this sponsor

Children's Hospital of Philadelphia →

Start the discussion