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

Study Overview

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

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.

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.

Congenital Hyperinsulinism (CHI)
Beckwith-Wiedemann Syndrome
Insulinoma

DRUG: 18F-DOPA

12-009528

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-07-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-27
First Submitted that Met QC Criteria 2013-08-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-02
First Posted (ACTUAL) 2013-08-05	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Susan Becker, RN, BSN, CCRC

Phone Number: 267-426-0269

Email: Beckers@chop.edu

Study Contact Backup

Name: Lisa States, MD

Phone Number: 267-425-7146

Email: States@chop.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Lisa States, MD, Children's Hospital of Philadelphia

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
Palmaz JC. New advances in endovascular technology. Tex Heart Inst J. 1997;24(3):156-9.
Breitwieser W, Price C, Schuster T. Identification of a gene encoding a novel zinc finger protein in Saccharomyces cerevisiae. Yeast. 1993 May;9(5):551-6. doi: 10.1002/yea.320090512.
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.
Shapiro E. The first textbook of electrocardiography. Thomas Lewis: Clinical Electrocardiography. J Am Coll Cardiol. 1983 Apr;1(4):1160-1. doi: 10.1016/s0735-1097(83)80120-x. No abstract available.

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