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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: Recruiting Phase 1 study of Congenital Hyperinsulinism and Insulinoma, sponsored by Cook Children's Health Care System.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Positron Emission Tomography will be used to determine whether or not the uptake of a radiopharmaceutical agent, Fluorodopa F 18, produced in a cyclotron located at a distance far from the imaging center will produce qualitatively adequate pancreatic images in patients with congenital hyperinsulinism

Interventions

  • DRUG Fluorodopa F 18

Study Locations (1)

Texas

  • Cook Children's Medical Center - Fort Worth

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2013-10-09
Est. Completion 2028-06
Phase Phase 1

What NCT02021604 shows while recruiting

NCT02021604 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 43-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (481% higher).

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 a single indexed study location in 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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Source: ClinicalTrials.gov NCT02021604, the US trial registry maintained by the National Library of Medicine. NCT02021604 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.