The Use of Fluorodopa F 18 Positron Emission Tomography Combined With Computed Tomography in Congenital Hyperinsulinism and Insulinoma

What this Trial Is About

Researchers are studying congenital hyperinsulinism (HI) and insulinoma, conditions where the pancreas produces too much insulin, causing dangerously low blood sugar levels that can lead to brain damage in newborns and children. This study evaluates whether an investigational drug called Fluorodopa F 18, used with a PET scan combined with CT imaging, can accurately locate areas of the pancreas causing the disease. The goal is to help surgeons remove only the affected part, potentially curing the patient and preventing further brain injury. Participants will receive a dose of Fluorodopa F 18 injected into a vein, followed by PET imaging for up to 70 minutes, alongside a CT scan with contrast to create detailed pancreatic images. These images will be compared to surgical biopsy results to assess accuracy. The study aims to determine the best way to interpret scan results and whether the imaging technique can guide successful surgery for both congenital HI and insulinoma. During the study, researchers will monitor the radioactivity of Fluorodopa F 18 after injection and compare the imaging findings with tissue samples obtained during surgery. The study includes patients who have not responded to medical treatment and are recommended for surgery. The primary outcome is the scan's accuracy in locating problematic pancreatic areas. Participants will be observed up to one month after surgery, with safety and imaging effectiveness evaluated throughout the process.

Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma