Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02021604 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 3 versions Re-verified since Jan 29, 2020, no change to tracked fieldsv8-v10
  2. Enrollment target: 50 to 250v7 Show 8 more changesShow less
    • Primary completion date: Jan 2019 to Jan 2028
    • Primary endpoints revised (2)
    • Study completion date: Jun 2019 to Jun 2028
    • Start date: Dec 2013 to Oct 9, 2013
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints expanded, about 22 words
    • Study description expanded, about 234 words
    • Study title expanded, about 2 words
  3. 2 versions Re-verified since Jul 27, 2015, no change to tracked fieldsv5-v6
  4. Study description shortened, about 2 wordsv4
  5. Interventions: 18FDOPA (Drug) to Fluorodopa F 18 (Drug)
    • Study description expanded, about 14 words
    • Eligibility criteria expanded, about 4 words
    • Study title expanded, about 2 words
    v3
  6. Interventions: FDOPA (Drug) to 18FDOPA (Drug)
    • Eligibility criteria revised
    • Study description revised
    • Study title revised
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02021604
Lead Sponsor Cook Children's Health Care System
Conditions
(from sponsor)		 Congenital Hyperinsulinism, Insulinoma
Related terms Congenital Hyperinsulinism, Hyperinsulinism, Hypoglycemia, Insulinoma
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov