Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorCook Children's Health Care System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with HI attending the Cook Children's Congenital Hyperinsulinism Center and being treated by an Endocrinologist which may be the PI or a partner of this clinician.
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
Inability to fast, defined as the inability to maintain a blood glucose >50 mg/dL for: 1) more than 12 hours for infants < 1 year of age; 2) more than 15 hours 1-3 years of age; 3) more than 18 hours over 3 years of age
no genetic testing results (e.g., due to insurance denial or parental refusal)
Disqualifiers
Patients who do not have a diagnosis of HI
Patients with genetic evidence of diffuse HI
Patients who are pregnant
Nursing mothers who are unwilling to discontinue breastfeeding their infant for 48 hours after Fluorodopa F 18 injection
Trial design
Design model
Single group
Treatments tested in this trial
Fluorodopa F 18
DrugA 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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Pancreatic Imaging with Fluorodopa F 18Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Radioactivity of 18F-DOPA following transport
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
Time frame
1 day2
Accuracy of PET imaging compared to intraoperative pancreatic biopsy in patients with congenital hyperinsulinism
Investigators will directly compare pancreatic images from Fluorodopa F 18 PET combined with Computed Tomography versus the gold-standard of histopathological findings at surgery in subjects who received a partial or complete pancreatectomy
Time frame
up to one monthSecondary outcomes
1
Accuracy of PET imaging compared to intraoperative pancreatic biopsy in patients with insulinoma
Investigators will directly compare pancreatic images from Fluorodopa F 18 PET combined with Computed Tomography versus the gold-standard of histopathological findings at surgery in subjects who received a partial or complete pancreatectomy
Time frame
up to one month2
Ratio of Standard Uptake Value max to sub max
Investigators will compare SUV max to SUV sub max at a ratio of the current 1.5, a suggested 1.3 and by using visual inspection of the images.
Time frame
up to one monthSponsors and contacts
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Source ClinicalTrials.gov