Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

Study Overview
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Brief Summary
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Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.

Detailed Description
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For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.

Official Title
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Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-labeled L-fluoro-DOPA PET Scan

Conditions
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Congenital Hyperinsulinism, Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy, CHI, PHHI

Intervention / Treatment
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* Drug: F-DOPA
* Radiation: PET scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any age, but primarily infants 0-6 months. Children with confirmed diagnosis of congenital hyperinsulinism. Exclusion Criteria: Cases in which surgery will not be considered by parents or guardians.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects who had PET and surgery<br>Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and are candidates to be scheduled for surgery for partial pancreatectomy. Eligible children will undergo PET imaging with F-DOPA prior to surgery. | Drug: F-DOPA<br>* 0.08-0.16 mCi/kg once<br>* Other names: 18F-DOPA;Radiation: PET scan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism | Comparison of PET scan results with outcome of surgery and histopathology results confirmed as focal or diffuse | up to 1 month post surgical intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of F-DOPA PET | Number of Participants with Adverse Events | 72 hours maximum or prior to pancreatic surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital Hyperinsulinism, Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy, CHI, PHHI, F-DOPA, L-fluoro-dihydroxyphenylalanine