RECRUITING

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

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Conditions

Congenital Hyperinsulinism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism

Quick Facts

Study Start:2016-11-03
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04205604

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:0 Days to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any age, but primarily infants 0-6 months given typical age of initial presentation.
  2. * 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)
  3. * Hypoglycemia uncontrolled with medical management (diazoxide, octreotide).
  4. * Able to withdraw medications in time to wash out prior to the scheduled PET scan.
  5. * Patients fulfilling criteria above but with uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy)
  6. * Normal hepatic and renal function.
  1. * Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).
  2. * Patients with hepatic or renal insufficiency.

Contacts and Locations

Principal Investigator

Miguel Hernandez Pampaloni, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: Miguel Pampaloni

  • Miguel Hernandez Pampaloni, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

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

Study Start Date2016-11-03
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2016-11-03
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Congenital Hyperinsulinism