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

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

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01916148
Enrollment
Unknown
Registered
2013-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

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.

Interventions

18F-DOPA is a PET (Positron Emission Tomography) scan radiotracer.

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Countries

United States

Contacts

Primary ContactSusan Becker, RN, BSN, CCRC
Beckers@chop.edu267-426-0269
Backup ContactLisa States, MD
States@chop.edu267-425-7146

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026