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

• Conditions: Congenital Hyperinsulinism (CHI); Beckwith-Wiedemann Syndrome; Insulinoma

• Registration Number: NCT01916148
• Lead Sponsor: Children's Hospital of Philadelphia

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.

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.

Study Timeline

• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States