Official Title
Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
Brief Summary

This purpose of this study is to determine the ability of an18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET (Positron Emission Tomography) scan todetect a focal lesion of hyperinsulinism and determine the location in patients withcongenital hyperinsulinism, Beckwith Wiedemann Syndrome and suspected insulinoma. Safetydata 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.

Available
Intermediate-size Population
Congenital Hyperinsulinism (CHI)
Beckwith-Wiedemann Syndrome
Insulinoma

Drug: 18F-DOPA

18F-DOPA is a PET (Positron Emission Tomography) scan radiotracer.
Other Name: 18F-fluoro-L-dihydroxyphenylalanine,18F-L-Fluoro-DOPA

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
United States
Locations

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States

Investigator: Lisa States, MD

Contacts

Susan Becker, RN, BSN, CCRC
267-426-0269
Beckers@chop.edu

Lisa States, MD
267-425-7146
States@chop.edu

Lisa States, MD, Principal Investigator
Children's Hospital of Philadelphia

Children's Hospital of Philadelphia
NCT Number
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)
MeSH Terms
Insulinoma
Congenital Hyperinsulinism
Nesidioblastosis
Beckwith-Wiedemann Syndrome
Hypoglycemia
Hyperinsulinism
Dihydroxyphenylalanine