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

NCT04205604 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 8F-Fluoro-L- DOPA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Sensitivity of Imaging

  To determine the sensitivity and specificity of FDOPA PET/CT in differentiating focal and diffuse forms of HI in infants with medically refractory hypoglycemia

  four weeks

• Accuracy of Imaging

  To determine the accuracy of FDOPA PET/CT localizing areas of islet cell adenomatosis within the pancreas in patients with focal HI, by identifying the area of abnormal uptake of the raioligand

  four weeks

Secondary Outcomes (1)

• Semiquantitative Imaging Assessment

  four weeks

Study Arms (1)

Single Arm,

EXPERIMENTAL

Patients with clinically diagnosed congenital hyperinsulinism

Drug: 18F-Fluoro Dopa Imaging

Interventions

18F-Fluoro Dopa Imaging DRUG

Imaging with 18F-Fluoro Dopa PET Imaging

Single Arm,

Eligibility Criteria

• Age: 0 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Miguel Pampaloni: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Congenital Hyperinsulinism

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypoglycemia

Study Officials

• Miguel Hernandez Pampaloni, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology & Medicine

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 19, 2019
• Study Start: November 3, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)