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64Cu-NODAGA-ZHER2:S1 is an investigational radiopharmaceutical imaging agent designed for positron emission tomography (PET) to detect and quantify Human Epidermal Growth Factor Receptor 2 (HER2) expression in tumors. It consists of a HER2-targeting Affibody molecule (ZHER2:S1) conjugated to the triaza chelator NODAGA and labeled with the positron-emitting radioisotope Copper-64 (64Cu). Affibody molecules are small (approx. 7 kDa) engineered protein scaffolds derived from the B-domain of staphylococcal protein A, offering high affinity and specificity for their targets. 64Cu-NODAGA-ZHER2:S1 is primarily used for the non-invasive stratification of patients with HER2-positive cancers, such as breast cancer, to determine eligibility for HER2-targeted therapies. While it demonstrated strong targeting properties in early studies, it has served as a benchmark for developing next-generation tracers with optimized biodistribution, specifically aimed at reducing hepatic uptake.
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