Clinical trial NCT01916148: 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
Official title: Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: 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)
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2013-08-05
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Lisa States, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Palmaz JC. New advances in endovascular technology. Tex Heart Inst J. 1997;24(3):156-9.
citation: 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.
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.
citation: 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.