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Title: Imaging biomarker roadmap for cancer studies.
Authors: O'Connor, J. P.
Aboagye, E. O.
Adams, J. E.
Aerts, H. J.
Barrington, S. F.
Beer, A. J.
Boellaard, R.
Bohndiek, S. E.
Brady, M.
Brown, G.
Buckley, D. L.
Chenevert, T. L.
Clarke, L. P.
Collette, S.
Cook, G. J.
deSouza, N. M.
Dickson, J. C.
Dive, C.
Evelhoch, J. L.
Faivre-Finn, C.
Gallagher, F. A.
Gilbert, F. J.
Gillies, R. J.
Goh, V.
Griffiths, J. R.
Groves, A. M.
Halligan, S.
Harris, A. L.
Hawkes, D. J.
Hoekstra, O. S.
Huang, E. P.
Hutton, B. F.
Jackson, E. F.
Jayson, G. C.
Jones, A.
Koh, D. M.
Lacombe, D.
Lambin, P.
Lassau, N.
Leach, M. O.
Lee, T. Y.
Leen, E. L.
Lewis, J. S.
Liu, Y.
Lythgoe, M. F.
Manoharan, P.
Maxwell, R. J.
Miles, K. A.
Morgan, Bruno
Morris, S.
Ng, T.
Padhani, A. R.
Parker, G. J.
Partridge, M.
Pathak, A. P.
Peet, A. C.
Punwani, S.
Reynolds, A. R.
Robinson, S. P.
Shankar, L. K.
Sharma, R. A.
Soloviev, D.
Stroobants, S.
Sullivan, D. C.
Taylor, S. A.
Tofts, P. S.
Tozer, G. M.
van Herk, M.
Walker-Samuel, S.
Wason, J.
Williams, K. J.
Workman, P.
Yankeelov, T. E.
Brindle, K. M.
McShane, L. M.
Jackson, A.
Waterton, J. C.
First Published: 11-Oct-2016
Publisher: Nature Publishing Group
Citation: Nature Reviews Clinical Oncology, 2016
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.
DOI Link: 10.1038/nrclinonc.2016.162
ISSN: 1759-4774
eISSN: 1759-4782
Version: Publisher Version
Status: Peer-reviewed
Type: Journal Article
Rights: 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
Appears in Collections:Published Articles, Dept. of Cancer Studies and Molecular Medicine

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