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

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT01916148
• Other study ID #: 12-009528
• Status: Available

Study information

• Verified date: April 2024
• Source: Children's Hospital of Philadelphia
• Contact: Susan Becker, RN, BSN, CCRC
• Phone: 267-426-0269
• Email: Beckers[@]chop.edu
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• 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

Related Conditions & MeSH terms

• Beckwith-Wiedemann Syndrome
• Congenital Hyperinsulinism
• Congenital Hyperinsulinism (CHI)
• Hyperinsulinism
• Hypoglycemia
• Insulinoma
• Nesidioblastosis

Intervention

Drug:
• 18F-DOPA
18F-DOPA is a PET scan radiotracer.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

External Links

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