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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: Completed Phase 2 study of Congenital Hyperinsulinism and Hyperinsulinism, sponsored by Children's Hospital of Philadelphia.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparison of PET scan results with outcome of surgery and histopathology results confirmed as focal or diffuse
Conditions Studied
Interventions
- DRUG F-DOPA
- RADIATION PET scan
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2004-12 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
What the finished NCT00674440 record still lists
NCT00674440 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, above the 63-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (68% higher).
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 a single indexed study location in 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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