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18F-NY104 is a novel small-molecule radiopharmaceutical specifically designed for positron emission tomography (PET) imaging of Carbonic Anhydrase IX (CAIX)-positive tumors. CAIX is a transmembrane glycoprotein that is minimally expressed in normal tissues but significantly overexpressed in various solid tumors, most notably clear cell renal cell carcinoma (ccRCC), due to the hypoxia-inducible factor-1 (HIF-1) pathway and VHL gene inactivation. 18F-NY104 utilizes an aluminum-fluoride ([18F]AlF) labeling strategy, which facilitates a simplified preparation process with high radiochemical yield and purity suitable for clinical application. Preclinical and clinical evaluations demonstrate that 18F-NY104 has high binding affinity for the extracellular catalytic domain of CAIX and superior pharmacokinetic properties compared to earlier tracers, exhibiting rapid tumor uptake and efficient clearance from non-target organs. It is primarily utilized for the non-invasive diagnosis, staging, and longitudinal monitoring of primary, recurrent, and metastatic renal cell carcinoma lesions.
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