Imaging biomarker roadmap for cancer studies

Research output: Contribution to journalReview articlepeer-review


  • James P B O'Connor
  • Eric O Aboagye
  • Judith E Adams
  • Hugo J W L Aerts
  • Sally F Barrington
  • Ambros J Beer
  • Ronald Boellaard
  • Sarah E Bohndiek
  • Michael Brady
  • Gina Brown
  • David L Buckley
  • Thomas L Chenevert
  • Laurence P Clarke
  • Sandra Collette
  • Gary J Cook
  • Nandita M deSouza
  • John C Dickson
  • Caroline Dive
  • Jeffrey L Evelhoch
  • Corinne Faivre-Finn
  • Ferdia A Gallagher
  • Fiona J Gilbert
  • Robert J Gillies
  • Vicky Goh
  • John R Griffiths
  • Ashley M Groves
  • Steve Halligan
  • Adrian L Harris
  • David J Hawkes
  • Otto S Hoekstra
  • Erich P Huang
  • Brian F Hutton
  • Edward F Jackson
  • Gordon C Jayson
  • Andrew Jones
  • Dow-Mu Koh
  • Denis Lacombe
  • Philippe Lambin
  • Nathalie Lassau
  • Martin O Leach
  • Ting-Yim Lee
  • Edward L Leen
  • Jason S Lewis
  • Yan Liu
  • Mark F Lythgoe
  • Prakash Manoharan
  • Ross J Maxwell
  • Kenneth A Miles
  • Bruno Morgan
  • Steve Morris
  • Tony Ng
  • Anwar R Padhani
  • Geoff J M Parker
  • Mike Partridge
  • Arvind P Pathak
  • Shonit Punwani
  • Andrew R Reynolds
  • Simon P Robinson
  • Lalitha K Shankar
  • Ricky A Sharma
  • Dmitry Soloviev
  • Sigrid Stroobants
  • Daniel C Sullivan
  • Stuart A Taylor
  • Paul S Tofts
  • Gillian M Tozer
  • Marcel van Herk
  • Simon Walker-Samuel
  • James Wason
  • Kaye J Williams
  • Paul Workman
  • Thomas E Yankeelov
  • Kevin M Brindle
  • Lisa M McShane
  • Alan Jackson
  • John C Waterton

External organisations

  • University of Manchester
  • Imperial College London
  • Manchester University Hospitals NHS Foundation Trust
  • Harvard Medical School
  • CRUK and EPSRC Comprehensive Imaging Centre at KCL and UCL, Kings College London, London, UK.
  • Department of Nuclear Medicine, University Hospital Ulm, Ulm, Germany.
  • University of Groningen
  • University of Cambridge
  • University of Oxford
  • Radiology Department, Royal Marsden Hospital, London, UK.
  • University of Leeds
  • University of Michigan
  • Cancer Imaging Program, National Cancer Institute, Bethesda, MD.
  • Biostatistics, EORTC, Brussels, Belgium.
  • The Institute of Cancer Research
  • University College London
  • Clinical and Experimental Pharmacology, CRUK Manchester Institute, Manchester, UK.
  • Translational Biomarkers, Merck &Co., Inc, West Point, PA.
  • Cancer Imaging and Metabolism, Moffitt Cancer Center, Tampa, FL.
  • Vrije Universiteit Medical Centre
  • Biometric Research Program, National Cancer Institute, Bethesda, MD.
  • University of Wisconsin-Madison
  • The Christie NHS Foundation Trust
  • Statistics Department, EORTC Headquarters, Brussels, Belgium.
  • Maastricht University
  • Gustave Roussy
  • Imaging Research Labs, Robarts Research Institute, London, Ontario, Canada.
  • Memorial Sloan Kettering Cancer Center
  • Newcastle University
  • University of Leicester
  • Mount Vernon Hospital
  • Johns Hopkins University
  • Molecular Imaging Center Antwerp, University of Antwerp, Antwerp, Belgium.
  • Duke University
  • University of Sussex
  • University of Sheffield
  • MRC Biostatistics Unit, Cambridge, UK.
  • The University of Texas at Austin
  • University College London Hospitals NHS Foundation Trust


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.


Original languageEnglish
Pages (from-to)169-186
Number of pages18
JournalNature Reviews Clinical Oncology
Issue number3
Early online date11 Oct 2016
Publication statusPublished - Mar 2017


  • Biomarkers, Tumor, Clinical Decision-Making, Cost-Benefit Analysis, Fluorodeoxyglucose F18, Folic Acid, Humans, Neoplasms, Organotechnetium Compounds, Positron-Emission Tomography, Prognosis, Radiopharmaceuticals, Reproducibility of Results, Research Design, Selection Bias, Consensus Development Conference, Journal Article, Review

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