Department of Cancer Systems Imaging, MD Anderson Cancer Center, Houston, TX, 77030, USA.
Department of Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, MI, 48201, USA.
Mol Imaging Biol. 2022 Feb;24(1):1-7. doi: 10.1007/s11307-021-01645-6. Epub 2021 Sep 20.
In oncology, biomarker research aimed to provide insights on cancer biology via positron emission tomography (PET) and single photon emission tomography (SPECT) imaging has seen an incredible growth in the past two decades. Despite the increased number of publications on PET/SPECT radiopharmaceuticals, the field lacked standardization of in vitro and in vivo parameters necessary for the characterization of any radiotracer. Through the efforts of the World Molecular Imaging Society Education Committee, this white paper lays down validation studies that are essential to chemically and biologically characterize new radiopharmaceuticals derived from small molecules, peptides or proteins. Finally, a brief overview of the steps toward translation is also presented.Herein, we discuss the following: Chemistry and radiochemistry metrics to establish the identity of the imaging agent. In vitro and in vivo studies to examine the radiotracer's mechanism of action, which includes target specificity, pharmacokinetics and in vivo metabolism.
在肿瘤学领域，通过正电子发射断层扫描（PET）和单光子发射断层扫描（SPECT）成像进行生物标志物研究旨在深入了解癌症生物学，在过去的二十年中取得了令人瞩目的发展。尽管关于 PET/SPECT 放射性药物的出版物数量有所增加，但该领域缺乏对任何示踪剂进行化学和生物学特征描述所需的体外和体内参数的标准化。通过世界分子影像学学会教育委员会的努力，本白皮书提出了验证研究，这些研究对于从小分子、肽或蛋白质衍生的新型放射性药物的化学和生物学特征描述至关重要。最后，还简要介绍了转化的步骤。本文讨论了以下内容：确定成像剂身份的化学和放射化学指标。研究放射性示踪剂作用机制的体外和体内研究，包括靶向特异性、药代动力学和体内代谢。
