Coprimary objectives were to evaluate both the sensitivity and specificity of TLX250-CDx PET/CT imaging in detecting ccRCC in patients with IDRM, using histology as standard of truth. 89 Zr-DFO-girentuximab PET/CT is well tolerated and can accurately and noninvasively identify and characterize IDRMs, showing promising utility for guiding surgical and treatment decisions.
89Zr-DFO-girentuximab (hereafter referred to as TLX250-CDx) is a diagnostic radiopharmaceutical for PET imaging that targets CAIX and has demonstrated clinical success in ccRCC imaging. Statistics will be descriptive with no formal hypothesis. The study is ongoing.