Using 18F-Fluoro-L-DOPA PET Imaging to Detect and Locate Focal Congenital Hyperinsulinism in Infants and Children

What this Trial Is About

This research aims to evaluate the use of 18F-Fluoro-L-DOPA PET imaging as a pre-operative tool to distinguish between focal and diffuse forms of congenital hyperinsulinism HI and to locate focal lesions in the pancreas. Congenital hyperinsulinism is a common cause of persistent low blood sugar in infants, often requiring surgery when medications do not work. Identifying focal lesions before surgery could help guide pancreatic resection more accurately. The study involves imaging patients diagnosed with congenital hyperinsulinism using 18F-Fluoro Dopa PET scans. This imaging technique is being assessed for its ability to detect and locate diseased areas in the pancreas. The trial is a single-arm phase 2 study where all participants receive the 18F-Fluoro Dopa imaging. Participants must stop certain medications before the scan to ensure accurate imaging results. Participants will undergo the PET scan, and researchers will measure the sensitivity and accuracy of the imaging within four weeks. Additional semi-quantitative assessments will also be performed. The study includes infants and children up to 18 years old, with careful monitoring of liver and kidney function. The total time for outcome measurement is four weeks after imaging to evaluate its diagnostic performance.

18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism