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Imaging Biomarkers in Clinical Trials

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Imaging Biomarkers

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Abstract

The role of noninvasive imaging in clinical trials has evolved, thanks both to improvements in conventional morphologic imaging and also to innovation in molecular and functional imaging techniques. In this chapter, some basic principles of clinical trials are explained, and the role of imaging biomarkers is discussed with examples. The main emphasis is on the application of imaging biomarkers as outcome measures in therapeutic drug trials, as inclusion criteria (patient selection and stratification), and as safety monitoring tools (measure harm or lack of harm). Despite the obvious value of imaging, the integration of imaging biomarkers into trials faces various challenges, such as the complexity of imaging techniques, lack of standardization across multivendor platforms, and paucity of optimized trial design and operational support. Some common pitfalls of imaging biomarker implementation in trials are listed and accompanied by proposed solutions. Finally, perspectives are given on how to increase imaging biomarker value in drug development and clinical practice.

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Author information

Authors and Affiliations

  1. European Organisation for Research and Treatment of Cancer, Headquarters, Brussels, Belgium

    Yan Liu

  2. Biomedical Imaging Institute, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK

    John C. Waterton

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  1. Yan Liu
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  2. John C. Waterton
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Correspondence to Yan Liu .

Editor information

Editors and Affiliations

  1. La Fe University and Polithecnic Hospital, University of Valencia, Valencia, Spain

    Luis Martí-Bonmatí

  2. La Fe University and Polithecnic Hospital, University of Valencia, Valencia, Spain

    Angel Alberich-Bayarri

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Liu, Y., Waterton, J.C. (2017). Imaging Biomarkers in Clinical Trials. In: Martí-Bonmatí, L., Alberich-Bayarri, A. (eds) Imaging Biomarkers. Springer, Cham. https://doi.org/10.1007/978-3-319-43504-6_21

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  • DOI: https://doi.org/10.1007/978-3-319-43504-6_21

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