An Expert Report on the Radiopharmaceutical 18F-PSMA-1007

I. Introduction to 18F-PSMA-1007

A. Overview of 18F-PSMA-1007 as a PET Radiotracer

[18F-PSMA-1007 is a novel diagnostic radiopharmaceutical designed for Positron Emission Tomography (PET) imaging. It specifically targets the Prostate-Specific Membrane Antigen (PSMA), a protein that is notably overexpressed on the surface of prostate cancer cells.][1][ As a fluorine-18 (18F) labeled PSMA-targeting ligand, 18F-PSMA-1007 enables the visualization of PSMA-positive lesions through PET imaging, offering detailed information about the extent and location of the disease.][2]

[The development of PSMA-targeted PET tracers, including 18F-PSMA-1007, represents a significant advancement in the field of prostate cancer diagnostics.][2][ These agents aim to provide enhanced diagnostic accuracy compared to conventional imaging modalities such as computed tomography (CT) and magnetic resonance imaging (MRI), thereby facilitating improved patient management strategies.][1][ 18F-PSMA-1007 is particularly recognized for its favorable imaging characteristics, which contribute to its growing clinical utility.][1][ The clinical value and novelty of 18F-PSMA-1007 are not solely derived from its ability to target PSMA, a characteristic shared by a class of similar agents. Its distinction lies significantly in the advantages conferred by the 18F radionuclide—such as a longer half-life enabling centralized production and potentially better image resolution than 68Ga-labeled agents—and its unique pharmacokinetic profile, most notably its predominant hepatobiliary excretion. This excretion pathway contrasts with the renal clearance of many other PSMA tracers, including 68Ga-PSMA-11 and some other 18F-labeled PSMA agents like 18F-DCFPyL, suggesting a specific developmental aim to optimize imaging in certain anatomical regions, particularly the pelvis where bladder activity from renally ex