Phase 2
Completed N=106
Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Congenital Hyperinsulinism · Hyperinsulinism · Persistent Hyperinsulinemic Hypoglycemia of Infancy · CHI
Source: ClinicalTrials.gov NCT00674440 ↗
Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism — 40; 6; 3; 46 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism |
40; 6; 3; 46 | — |
| SECONDARY Safety of F-DOPA PET |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT00674440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.