Imaging biomarker roadmap for cancer studies

Abstract

Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing 'translational gaps' through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored 'roadmap'. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use.

Metadata

Item Type:	Article
Authors/Creators:	O'Connor, JPB Aboagye, EO Adams, JE Aerts, HJWL Barrington, SF Beer, AJ Boellaard, R Bohndiek, SE Brady, M Brown, G Buckley, DL https://orcid.org/0000-0001-6659-8365 Chenevert, TL Clarke, LP Collette, S Cook, GJ DeSouza, NM Dickson, JC Dive, C Evelhoch, JL Faivre-Finn, C Gallagher, FA Gilbert, FJ Gillies, RJ Goh, V Griffiths, JR Groves, AM Halligan, S Harris, AL Hawkes, DJ Hoekstra, OS Huang, EP Hutton, BF Jackson, EF Jayson, GC Jones, A Koh, D-M Lacombe, D Lambin, P Lassau, N Leach, MO Lee, T-Y Leen, EL Lewis, JS Liu, Y Lythgoe, MF Manoharan, P Maxwell, RJ Miles, KA Morgan, B Morris, S Ng, T Padhani, AR Parker, GJM Partridge, M Pathak, AP Peet, AC Punwani, S Reynolds, AR Robinson, SP Shankar, LK Sharma, RA Soloviev, D Stroobants, S Sullivan, DC Taylor, SA Tofts, PS Tozer, GM Van Herk, M Walker-Samuel, S Wason, J Williams, KJ Workman, P Yankeelov, TE Brindle, KM McShane, LM Jackson, A Waterton, JC
Copyright, Publisher and Additional Information:	© 2016 Macmillan Publishers Limited, part of Springer Nature. This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
Keywords:	Biomarkers; Cancer imaging; Diagnosis; Drug discovery and development
Dates:	Accepted: 5 May 2016 Published (online): 11 October 2016 Published: March 2017
Institution:	The University of Leeds
Academic Units:	The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Cardiovascular and Metabolic Medicine (LICAMM) > Division of Biomedical Imaging (Leeds)
Depositing User:	Symplectic Publications
Date Deposited:	06 Jan 2017 12:26
Last Modified:	05 Oct 2017 16:24
Published Version:	https://doi.org/10.1038/nrclinonc.2016.162
Status:	Published
Publisher:	Nature Publishing Group
Identification Number:	10.1038/nrclinonc.2016.162
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:110158

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Imaging biomarker roadmap for cancer studies

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