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NCT01468454 · ClinicalTrials.gov registry record · Phase 2

Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia

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

Completed
Registry status
Phase 2
Development phase
130
Enrollment target

NCT01468454 is a Phase 2 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 130 participants.

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The verdict

NCT01468454, a Phase 2 study, has completed, sponsored by Children's Hospital of Philadelphia.

COMPLETED
Registry status
Phase 2
Development phase
130 participants
Enrollment target

Study 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.

Interventions

  • DRUG 18 F-DOPA

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2009-01
Est. Completion 2018-02
Phase Phase 2

Sponsor

Children's Hospital of Philadelphia

431 total trials

What the Registry Record Tells You About NCT01468454

The ClinicalTrials.gov registry entry for NCT01468454 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which 18 F-DOPA is the first listed.

NCT01468454 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01468454 about?

NCT01468454 is a clinical study titled "Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia". 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 hy...

What is the current status of trial NCT01468454?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2009-01. Estimated completion is 2018-02.

What interventions are being tested in trial NCT01468454?

The interventions under investigation include: 18 F-DOPA (DRUG).

Who is sponsoring clinical trial NCT01468454?

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

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

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.