OncoMatch/Clinical Trials/NCT02021604
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
Is NCT02021604 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Fluorodopa F 18 for congenital hyperinsulinism.
Treatment: Fluorodopa F 18 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Biomarker criteria
Required: ABCC8 no autosomal recessive mutations on the maternal allele
no autosomal recessive mutations in ABCC8 or KCNJ11 on the maternal allele
Required: KCNJ11 no autosomal recessive mutations on the maternal allele
no autosomal recessive mutations in ABCC8 or KCNJ11 on the maternal allele
Required: ABCC8 no autosomal dominant mutations
no autosomal dominant mutations in ABCC8 or KCNJ11
Required: KCNJ11 no autosomal dominant mutations
no autosomal dominant mutations in ABCC8 or KCNJ11
Demographics
Prior therapy
Must have received: anti-hypoglycemic medications (diazoxide, octreotide)
Hypoglycemia (blood glucose <70 m/dL) on a single measure despite the use of anti-hypoglycemic medications, if applicable to the individual patient, including and limited to diazoxide or octreotide
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cook Children's Medical Center · Fort Worth, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT02021604 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received anti-hypoglycemic medications.
Does this trial require ABCC8?
Yes, ABCC8 no autosomal recessive mutations on the maternal allele is a required biomarker for enrollment.
Does this trial require KCNJ11?
Yes, KCNJ11 no autosomal recessive mutations on the maternal allele is a required biomarker for enrollment.
Does this trial require ABCC8?
Yes, ABCC8 no autosomal dominant mutations is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 18 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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