CompletedPhase 2

Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

United States106 participantsStarted 2004-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism

Timeframe: up to 1 month post surgical intervention

Trial details

NCT IDNCT00674440

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-12

Results submitted2022-07-20

View on ClinicalTrials.gov More Congenital Hyperinsulinism trials