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Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

NCT00674440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2022-11-09

Study results available
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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.

Conditions

  • Congenital Hyperinsulinism
  • Hyperinsulinism
  • Persistent Hyperinsulinemic Hypoglycemia of Infancy
  • CHI
  • PHHI

Interventions

DRUG

F-DOPA

0.08-0.16 mCi/kg once

RADIATION

PET scan

Sponsors & Collaborators

Principal Investigators

  • Lisa J States, MD · Children's Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00674440 on ClinicalTrials.gov