Since the development of amyloid tracers for PET imaging, there has been interest in quantifying amyloid burden in the brains of patients with Alzheimer disease. Quantitative amyloid PET imaging is poised to become a valuable approach in disease staging, theranostics, monitoring, and as an outcome measure for interventional studies. Yet, there are significant challenges and hurdles to overcome before it can be implemented into widespread clinical practice. On November 17, 2022, the U.S. Food and Drug Administration, Society of Nuclear Medicine and Molecular Imaging, and Medical Imaging and Technology Alliance cosponsored a public workshop comprising experts from academia, industry, and government agencies to discuss the role of quantitative brain amyloid PET imaging in staging, prognosis, and longitudinal assessment of Alzheimer disease. The workshop discussed a range of topics, including available radiopharmaceuticals for amyloid imaging; the methodology, metrics, and analytic validity of quantitative amyloid PET imaging; its use in disease staging, prognosis, and monitoring of progression; and challenges facing the field. This report provides a high-level summary of the presentations and the discussion.

自从开发出用于 PET 成像的淀粉样蛋白示踪剂以来，人们一直对量化阿尔茨海默病患者大脑中的淀粉样蛋白负荷产生了兴趣。定量淀粉样蛋白 PET 成像有望成为疾病分期、治疗诊断、监测以及介入研究结果衡量的一种有价值的方法。然而，在将其广泛应用于临床实践之前，还需要克服重大挑战和障碍。 2022年11月17日，美国食品药品监督管理局、核医学与分子影像学会、医学影像与技术联盟共同主办了由学术界、工业界和政府机构专家组成的公共研讨会，讨论定量脑淀粉样蛋白PET的作用阿尔茨海默病的分期、预后和纵向评估中的成像。研讨会讨论了一系列主题，包括用于淀粉样蛋白成像的可用放射性药物；定量淀粉样蛋白 PET 成像的方法、指标和分析有效性；其在疾病分期、预后和进展监测中的应用；以及该领域面临的挑战。本报告提供了演讲和讨论的高级摘要。