Production of [89Zr]Oxinate4 and cell radiolabeling for human use

[⁸⁹ Zr]Oxinate₄ is a Positron Emission Tomography (PET) tracer for cell radiolabeling that can enable imaging techniques to help better understand cell trafficking in various diseases. Although several groups have synthetized this compound for use in preclinical studies, there is no available data regarding the production of [⁸⁹ Zr]Oxinate₄ for human use. In this report, we describe the detailed production of [⁸⁹ Zr]Oxinate₄ under USP <823> and autologous leukocyte radiolabeling under USP <797>. The final product presented high radiochemical purity and stability at 24 h post synthesis (>99%) and passed in all quality control assays required for clinical use. [⁸⁹ Zr]Oxinate₄ did not compromise the white blood cells viability and did not show considerable cellular efflux up to 3 h post labeling. The translation of this technique into human use can provide insight into several disease mechanisms since [⁸⁹ Zr]Oxinate₄ has the potential to label any cell subset of interest.