Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
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|ClinicalTrials.gov Identifier: NCT02021604|
Recruitment Status : Recruiting
First Posted : December 27, 2013
Last Update Posted : December 12, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Hyperinsulinism Insulinoma||Drug: Fluorodopa F 18||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Fluorodopa F 18 Positron Emission Tomography Combined With Computed Tomography in Congenital Hyperinsulinism and Insulinoma|
|Actual Study Start Date :||October 9, 2013|
|Estimated Primary Completion Date :||January 2028|
|Estimated Study Completion Date :||June 2028|
|Experimental: Pancreatic Imaging with Fluorodopa F 18||
Drug: Fluorodopa F 18
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.
- Radioactivity of 18F-DOPA following transport [ Time Frame: 1 day ]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
- Accuracy of PET imaging compared to intraoperative pancreatic biopsy in patients with congenital hyperinsulinism [ Time Frame: up to one month ]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
- Accuracy of PET imaging compared to intraoperative pancreatic biopsy in patients with insulinoma [ Time Frame: up to one month ]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
- Ratio of Standard Uptake Value max to sub max [ Time Frame: up to one month ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021604
|Contact: Deborah Rafferty, PhD||682-303-1363||Deborah.Rafferty@cookchildrens.org|
|United States, Texas|
|Cook Children's Medical Center||Recruiting|
|Fort Worth, Texas, United States, 76104|
|Principal Investigator: Paul Thornton, MD|
|Principal Investigator:||Paul Thornton, MD||Cook Children's Health Care System|