Department of Diagnostic Imaging, M.D. Anderson Cancer Center, Houston, Texas;
Department of Radiology, University of Michigan, Ann Arbor, Michigan.
J Nucl Med Technol. 2024 Sep 5;52(3):184-191. doi: 10.2967/jnmt.123.266588.
This article is intended to introduce nuclear medicine technologists (NMTs) to the nuances of radiopharmaceutical therapy clinical trials. Here, we outline the potential roles and responsibilities of the NMT in clinical trials and provide context on different aspects of radionuclide therapy. The regulatory process involving investigational therapeutic radiopharmaceuticals is seldom taught to NMT students, nor is it included in the entry-level nuclear medicine certification examinations. Often, NMTs must spend significant time preparing for therapeutic clinical trials on their own, using multiple academic sources, seeking advice from various health care professionals, and reviewing numerous trial-specific manuals to recognize the detailed requirements. The emergence of theranostics has spurred an increase in the development of therapeutic radiopharmaceuticals. Investigators with a robust nuclear medicine background are required to help develop successful therapeutic clinical trials, and well-informed NMTs are crucial to the success of such trials. This article follows a series of previous publications from the Society of Nuclear Medicine and Molecular Imaging Clinical Trials Network research series for technologists and is intended to guide the investigational radiopharmaceutical landscape.
本文旨在向核医学技术人员（NMT）介绍放射性药物治疗临床试验的细微差别。在这里，我们概述了 NMT 在临床试验中的潜在角色和职责，并提供了有关放射性核素治疗不同方面的背景信息。涉及研究性治疗放射性药物的监管过程很少教授给 NMT 学生，也不包括在入门级核医学认证考试中。通常，NMT 必须花费大量时间自行准备治疗性临床试验，使用多种学术资源，向各种医疗保健专业人员寻求建议，并审查众多特定于试验的手册，以识别详细要求。治疗诊断学的出现促使治疗性放射性药物的开发有所增加。需要具有强大核医学背景的研究人员来帮助开发成功的治疗性临床试验，而知情的 NMT 对于此类试验的成功至关重要。本文遵循了来自核医学与分子影像学临床试验网络研究系列的一系列先前的技术人员出版物，旨在指导研究性放射性药物领域。
