At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 106 enrolled
Drug / intervention
F-DOPA +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-labeled L-fluoro-DOPA PET Scan
In Brief
A Phase 2 clinical trial evaluating F-DOPA and PET scan for Congenital Hyperinsulinism and 4 related conditions. Completed, enrolled 106 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Hyperinsulinism, Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy, CHI, PHHI
CountriesUnited States
CollaboratorsUniversity of Pennsylvania
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2004
First PostedMay 2008
Primary CompletionDec 2008
Study CompletionJan 2009
TodayJul 2026
First PostedMay 7, 2008
Enrollment StartDec 1, 2004
Primary CompletionDec 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.2 years ago
Interventions
F-DOPAdrug
0.08-0.16 mCi/kg once
PET scanradiation