Phase 2
N=106
Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Congenital Hyperinsulinism · Hyperinsulinism · Persistent Hyperinsulinemic Hypoglycemia of Infancy · CHI · PHHI
Bottom Line
View on ClinicalTrials.gov: NCT00674440 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism — 40; 6; 3; 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- F-DOPA (Drug); PET scan (Radiation)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Dec 2008
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 |
— | — |
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.
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.