Sofie Biosciences recently received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a clinical trial for a PET radiotracer based on fibroblast activation protein inhibitor (FAPI).
The company will now lead a phase II, multicenter, single-blind, nonrandomized study of its gallium-68 FAPI-46 PET radiotracer for imaging patients with pancreatic ductal adenocarcinoma. This comes after a 30-day review with the FDA.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
