CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
18 F-DOPAdrug
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.

Search/NCT01468454
NCT01468454Phase 2Completed
CompareCT.gov

A Phase II Safety and Efficacy Study of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Children With Hyperinsulinemic Hypoglycemia

Children's Hospital of Philadelphia·interventional·Posted Nov 9, 2011·Updated Oct 13, 2022

In Brief

A Phase 2 clinical trial evaluating 18 F-DOPA for Congenital Hyperinsulinism (CHI) and Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI). Completed, enrolled 130 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Hyperinsulinism (CHI), Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
CountriesUnited States
CollaboratorsUniversity of Pennsylvania

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 9, 2011
Enrollment StartJan 1, 2009
Primary CompletionJun 1, 2014
Study CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 14.6 years ago

Interventions

18 F-DOPAdrug

1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA