Actively Recruiting

Phase 2
Age: 0Days - 18Years
All Genders
NCT04205604

18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism

Led by Miguel Pampaloni · Updated on 2026-05-01

50

Participants Needed

1

Research Sites

525 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this project is to determine the role of FDOPA/PET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas to guide surgical resection.

CONDITIONS

Official Title

18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism

Who Can Participate

Age: 0Days - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Any age, primarily infants 0-6 months due to typical age of initial presentation
  • Diagnosis of focal or diffuse congenital hyperinsulinism based on clinical criteria and confirmed by genetic testing for mutations in ABCC8 and KCNJ1
  • Hypoglycemia not controlled with medical treatment such as diazoxide or octreotide
  • Able to stop medications in time to wash out before the PET scan
  • Patients with uncontrolled hypoglycemia after partial or near-total pancreatectomy
  • Normal liver and kidney function
Not Eligible

You will not qualify if you...

  • Treatment with third-line medications for hyperinsulinism like nifedipine or glucagon
  • Liver or kidney insufficiency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism | DecenTrialz