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NCT02021604 · ClinicalTrials.gov registry record · Phase 1
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
A Phase 1 study of Congenital Hyperinsulinism and Insulinoma, sponsored by Cook Children's Health Care System.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT02021604 is a Phase 1 study of Congenital Hyperinsulinism and Insulinoma that is actively recruiting participants, run by Cook Children's Health Care System. The registered enrollment target is 250 participants, above the 43-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (481% higher). The trial reports 1 study location across 1 state.
The verdict
NCT02021604, a Phase 1 study of Congenital Hyperinsulinism and Insulinoma, is actively recruiting participants, sponsored by Cook Children's Health Care System.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
Low blood sugars are known to cause brain damage in newborn babies. One of the most common causes of low blood sugars persisting beyond the new born period is a condition called congenital hyperinsulinism (HI). This is a disease whereby the pancreas secretes too much insulin and causes low blood sugars. Twenty to forty percent of these babies will have brain damage. There are two forms of this disease. In one form only a small part of the pancreas makes too much insulin (focal HI) and in the other, the whole pancreas make too much insulin (diffuse HI). Another very similar disease is insulinoma which occurs after birth, but also causes hyperinsulinism. If a surgeon could know which part of the pancreas has the focal lesion he could remove it and cure the patient. The purpose of this study is to investigate whether a new investigational drug called Fluorodopa F 18, when used with a PET scan, can find the focal lesion and guide the surgeon to remove it, thus curing the patient and preventing further brain damage.
Conditions Studied
Interventions
- DRUG Fluorodopa F 18
Study Locations (1)
Texas
- Cook Children's Medical Center - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2013-10-09 |
| Est. Completion | 2028-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02021604
The ClinicalTrials.gov registry entry for NCT02021604 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 43-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (481% higher). The listed sponsor is Cook Children's Health Care System, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Congenital Hyperinsulinism appearing as the primary indexed condition, and to 1 intervention - of which Fluorodopa F 18 is the first listed.
NCT02021604 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02021604 about?
NCT02021604 is a clinical study titled "Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma". Low blood sugars are known to cause brain damage in newborn babies. One of the most common causes of low blood sugars persisting beyond the new born period is a condition called congenital hyperinsulinism (HI). This is a disease whereby the pancreas secretes too much insulin and causes low blood sug...
What is the current status of trial NCT02021604?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2013-10-09. Estimated completion is 2028-06.
What conditions does trial NCT02021604 study?
This clinical trial studies the following conditions: Congenital Hyperinsulinism, Insulinoma.
What interventions are being tested in trial NCT02021604?
The interventions under investigation include: Fluorodopa F 18 (DRUG).
Who is sponsoring clinical trial NCT02021604?
This trial is sponsored by Cook Children's Health Care System, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02021604 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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