Clinical trial NCT00674440: Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Official title: Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-labeled L-fluoro-DOPA PET Scan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congenital Hyperinsulinism
Hyperinsulinism
Persistent Hyperinsulinemic Hypoglycemia of Infancy
CHI
PHHI
Keywords: Congenital Hyperinsulinism
Hyperinsulinism
Persistent Hyperinsulinemic Hypoglycemia of Infancy
CHI
PHHI
F-DOPA
L-fluoro-dihydroxyphenylalanine
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2008-05-07
Enrollment: 106
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism
timeFrame: up to 1 month post surgical intervention
Secondary outcomes:
measure: Safety of F-DOPA PET
timeFrame: 72 hours maximum or prior to pancreatic surgery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Lisa J States, MD
role: PRINCIPAL_INVESTIGATOR
References:
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