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NCT00674440 · ClinicalTrials.gov registry record · Phase 2

Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

A Phase 2 study of Congenital Hyperinsulinism and Hyperinsulinism, sponsored by Children's Hospital of Philadelphia.

Completed
Registry status
Phase 2
Development phase
106
Enrollment target
1
Study location

NCT00674440 is a Phase 2 study of Congenital Hyperinsulinism and Hyperinsulinism that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 106 participants, above the 63-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (68% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00674440, a Phase 2 study of Congenital Hyperinsulinism and Hyperinsulinism, has completed, sponsored by Children's Hospital of Philadelphia.

COMPLETED
Registry status
Phase 2
Development phase
106 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG F-DOPA
  • RADIATION PET scan

Study Locations (1)

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2004-12
Est. Completion 2009-01
Phase Phase 2

Sponsor

Children's Hospital of Philadelphia

431 total trials

What the Registry Record Tells You About NCT00674440

The ClinicalTrials.gov registry entry for NCT00674440 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 63-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (68% higher). The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Congenital Hyperinsulinism appearing as the primary indexed condition, and to 2 interventions - of which F-DOPA is the first listed.

NCT00674440 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00674440 about?

NCT00674440 is a clinical study titled "Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism". 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 ...

What is the current status of trial NCT00674440?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2004-12. Estimated completion is 2009-01.

What conditions does trial NCT00674440 study?

This clinical trial studies the following conditions: Congenital Hyperinsulinism, Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy, CHI, PHHI.

What interventions are being tested in trial NCT00674440?

The interventions under investigation include: F-DOPA (DRUG), PET scan (RADIATION).

Who is sponsoring clinical trial NCT00674440?

This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00674440 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.