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

ConditionCongenital Hyperinsulinism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age0-18
SponsorMiguel Pampaloni

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Hypoglycemia uncontrolled with medical management (diazoxide, octreotide).

Able to withdraw medications in time to wash out prior to the scheduled PET scan.

Disqualifiers

Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).

Patients with hepatic or renal insufficiency.

Trial design

Design model

Single group

Treatments tested in this trial

  • 18F-Fluoro Dopa Imaging

    Drug

    Imaging with 18F-Fluoro Dopa PET Imaging

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Single Arm,Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
four weeks
2

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

Time frame
four weeks

Secondary outcomes

1

Semiquantitative Imaging Assessment

o determine whether data from FDOPA PET/CT can accurately quantify pancreatic islet cell mass in patients with HI (normal pancreas, areas of adenomatosis in focal HI and diseased pancreas in diffuse HI) by quantifying the standardized uptake value (SUV) of FDOPA of and correlating with histologic findings.

Time frame
four weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Miguel Pampaloni

Lead sponsor

University of California, San Francisco

Sponsor institution

Source ClinicalTrials.gov
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