Using 18F-FluoroLDOPA PET imaging to find focal congenital hyperinsulinism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to evaluate the effectiveness of 18F-FluoroLDOPA PET imaging as a pre-operative diagnostic tool for distinguishing between focal and diffuse congenital hyperinsulinism. The study focuses on locating focal lesions in the pancreas that can be surgically removed to treat the condition. Congenital hyperinsulinism often leads to severe hypoglycemia in infants, and current imaging methods are inadequate for identifying the specific areas of dysfunction. By utilizing PET imaging, the study seeks to improve surgical outcomes for affected patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Any age, but primarily infants 0-6 months given typical age of initial presentation.
* Children with diagnosis of FoHI or DiHI based on clinical criteria (fasting hypoglycemia accompanied by inadequate suppression of plasma insulin, inappropriately low plasma free fatty acid and plasma-hydroxybutyrate concentrations, and an inappropriate glycemic response to glucagon injection)

  o confirmed by genetic testing for mutations in ABCC8 and KCNJ1 was1.
* Hypoglycemia uncontrolled with medical management (diazoxide, octreotide).
* Able to withdraw medications in time to wash out prior to the scheduled PET scan.
* Patients fulfilling criteria above but with uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy)
* Normal hepatic and renal function.

Exclusion Criteria:

* Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).
* Patients with hepatic or renal insufficiency.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Miguel Hernandez Pampaloni, MD, PhD — University of California, San Francisco

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.