Status and trends in the development of clinical diagnostic agents.
Status and trends in the development of clinical diagnostic agents.
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DOI：
10.1002/wnan.1441
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发表时间：
2017-07
期刊：
影响因子：
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通讯作者：
Tatjana Opacic;V. Paefgen;T. Lammers;F. Kiessling
中科院分区：
文献类型：
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作者：
Tatjana Opacic;V. Paefgen;T. Lammers;F. Kiessling
造影剂（CA）在临床实践中常规使用，以改善疾病的诊断并监测治疗反应。大多数CA由小分子组成，这些小分子由于血管异常（例如灌注和渗透性的变化）而积聚在病理部位。对于许多疾病，通过对比增强成像可以实现高诊断准确性。这意味着新的 CA 只有在诊断准确性、安全性和成本方面表现出卓越的性能，支持新的成像模式，或者与治疗的改进直接相关（例如作为伴随诊断），才能在转化中取得成功。不幸的是，科学界往往没有仔细考虑这些基本要求，导致概念临床转化的机会很低。因此，毫不奇怪的是，尽管出版物数量稳步增加，但在新诊断方法的临床批准方面却出现了完全相反的趋势。事实上，除了PET示踪剂之外，在过去的十年中，只有极少数的CA获得了FDA或EMA的批准。此外，由于市场潜力低、自有产品竞争激烈、临床表现欠佳或安全问题，制造商已经停产了几种已批准的产品。这篇综述文章讨论了已批准用于临床成像模式的诊断探针的现状，重点关注 CA 开发的新趋势。在此背景下，将介绍并讨论图像引导手术、纳米医学或治疗诊断学等新兴领域的分子靶向诊断或探针的临床转化。 WIREs Nanomed Nanobiotechnol 2017，9：e1441。 doi: 10.1002/wnan.1441 如需与本文相关的更多资源，请访问 WIREs 网站。
Contrast agents (CA) are routinely used in clinical practice to improve the diagnosis of diseases and to monitor therapy response. The majority of CA comprises small molecules accumulating at pathological sites due to vascular abnormalities, such as changes in perfusion and permeability. For many diseases, high diagnostic accuracy can be achieved with contrast-enhanced imaging. This means that new CA will only succeed in translation if they either show superior performance with respect to diagnostic accuracy, safety and cost, support a new imaging modality, or are directly linked to the refinement of therapy, e.g., as a companion diagnostic. Unfortunately, these basic demands are often not carefully considered by the scientific community, leading to concepts with low chances of clinical translation. Thus, it is not surprising that, despite steadily increasing numbers of publications, there is quite the opposite trend when it comes to the clinical approval of new diagnostics. As a matter of fact, except for PET tracers, in the last decade, only a handful of CA received FDA or EMA approval. Furthermore, several approved products were discontinued by the manufacturers because of low market potential, a competitive own product, suboptimal clinical performance, or safety concerns. This review article discusses the current status of approved diagnostic probes for clinical imaging modalities, with a focus on new trends in CA development. In this context, molecularly targeted diagnostics or probes for emerging fields, such as image-guided surgery, nanomedicine, or theranostics, will be introduced and discussed with regard to their clinical translation. WIREs Nanomed Nanobiotechnol 2017, 9:e1441. doi: 10.1002/wnan.1441 For further resources related to this article, please visit the WIREs website.