Recruiting
Phase 2

18FluoroLDOPA PET

Sponsor:

Miguel Pampaloni

Code:

NCT04205604

Conditions

Congenital Hyperinsulinism

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

18F-Fluoro Dopa Imaging

Study Details

Brief summary:

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

Congenital Hyperinsulinism

Study ID

NCT04205604

Start date

Nov 3, 2016

Status verified date

Apr, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Single Arm,

Patients with clinically diagnosed congenital hyperinsulinism

Interventions

18F-Fluoro Dopa Imaging

Imaging with 18F-Fluoro Dopa PET Imaging

Primary outcome measure

  • Sensitivity of Imaging [ Time Frame: four weeks ]
  • Accuracy of Imaging [ Time Frame: four weeks ]

Central Contacts and Locations

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Miguel Hernandez Pampaloni, MD, PhD

415-353-1886

More Information

Sponsor

Miguel Pampaloni

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Miguel Pampaloni on 2026-05-01.