Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Cook Children's Health Care System
Study ID
NCT02021604
Phase
PHASE1
Status
Recruiting
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Conditions

  • Congenital Hyperinsulinism
  • Insulinoma

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Fluorodopa F 18 — DRUG
    A dose of Fluorodopa F 18, 3-6 MBq/Kg (0.08-0.16 mCi/kg), will be injected intravenously into the subject under the direct supervision of the radiology sub-investigator. Then, the PET imaging procedure will begin and proceed for up to 70 minutes after injection. An abdominal CT image will be made using intravenous contrast. Both images, PET and CT, will be co-localized by the radiologist for interpretation.

Study Details

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.

Key Dates

Start date
Oct 9, 2013
Status verified
Jul 2024
Primary completion
Jan 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Pancreatic Imaging with Fluorodopa F 18

Primary Outcome Measure

Radioactivity of 18F-DOPA following transport [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cook Children's Medical CenterFort WorthTexas76104
Paul Thornton, MD (PRINCIPAL_INVESTIGATOR)

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Cook Children's Medical Center· Fort Worth, TX

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