CompletedPhase 2

Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia

United States130 participantsStarted 2009-01

Plain-language summary

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas. In this study, researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery. Eligible participants in this study will have positron emission tomography/computerized tomography (PET/CT) scans with F-DOPA prior to surgery.

Who can participate

SexALL

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Inclusion Criteria: * Infants and children with a clinical diagnosis of hyperinsulinism who are suspected to have focal disease and are surgical candidates for pancreatectomy Exclusion Criteria: * Pregnant or lactating females * Any other major illness or condition that might substantially increase the risk associated with the subject's participation in this study.

What they're measuring

Accuracy of 18F-DOPA PET/CT Scans to Detect Focal Lesions in Children With Congenital Hyperinsulinism

Timeframe: Surgery typically occured within a week post PET

Trial details

NCT IDNCT01468454

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

Results submitted2021-07-12

View on ClinicalTrials.gov More Congenital Hyperinsulinism (CHI) trials