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
  • Department of Clinical Radiology, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.
  • Department of Radiation Oncology, Harvard Medical School, Boston, MA.
  • CRUK and EPSRC Comprehensive Imaging Centre at KCL and UCL, Kings College London, London, UK.
  • Department of Nuclear Medicine, University Hospital Ulm, Ulm, Germany.
  • Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, Groningen, The Netherlands.
  • University of Cambridge
  • CRUK and EPSRC Cancer Imaging Centre, University of Oxford, Oxford, UK.
  • Radiology Department, Royal Marsden Hospital, London, UK.
  • University of Leeds
  • Department of Radiology, University of Michigan, Ann Arbor, MI.
  • Cancer Imaging Program, National Cancer Institute, Bethesda, MD.
  • Biostatistics, EORTC, Brussels, Belgium.
  • CRUK Cancer Imaging Centre, The Institute of Cancer Research, London, UK.
  • CRUK and EPSRC Cancer Imaging Centre at KCL and UCL, University College London, London, UK.
  • 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.
  • Department of Radiology and Nuclear Medicine, VU University Medical Centre, Amsterdam, The Netherlands.
  • Biometric Research Program, National Cancer Institute, Bethesda, MD.
  • Department of Medical Physics, University of Wisconsin, Madison, WI.
  • Medical Physics, The Christie Hospital NHS Foundation Trust, Manchester, UK.
  • Statistics Department, EORTC Headquarters, Brussels, Belgium.
  • Department of Radiation Oncology, University of Maastricht, Maastricht, Netherlands.
  • Department of Imaging, Gustave Roussy Cancer Campus, Villejuif, France.
  • Imaging Research Labs, Robarts Research Institute, London, Ontario, Canada.
  • Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY.
  • Centre for Advanced Biomedical Imaging, University College London, London, UK.
  • Newcastle University
  • University of Leicester
  • From the Centre for the Developing Brain, King's College London (D.A., N.T., A.D.E.), Institute for Women's Health, University College London (N.M., P.B.), Institute of Clinical Sciences, Imperial College London (D.A., A.D.), and Homerton University Hospital (O.K.), London, the National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Oxford (B.S., O.E., J.G., E.J., L.L., O.O.), Royal Maternity Hospital, Belfast (H.L.H.), University of Leeds, Leeds (M.L.), and University of Bristol, Bristol (M.T., A.W.) - all in the United Kingdom.
  • Paul Strickland Scanner Centre, Mount Vernon Hospital, London, UK.
  • Department of Radiology, The Johns Hopkins University School of Medicine, Baltimore, MD.
  • Birmingham Centre for Genome Biology and Institute of Cancer and Genomics, Medical and Dental School, University of Birmingham, Edgbaston, B15 2TT, UK. Electronic address:
  • Breakthrough Breast Cancer Research Centre, The Institute of Cancer Research, London
  • Molecular Imaging Center Antwerp, University of Antwerp, Antwerp, Belgium.
  • Department of Radiology, Duke University School of Medicine, Durham, NC.
  • Division of Medical Education, Brighton and Sussex Medical School, University of Sussex
  • University of Sheffield
  • MRC Biostatistics Unit, Cambridge, UK.
  • CRUK Cancer Therapeutics Unit, The Institute of Cancer Research, London, UK.
  • Institute of Computational Engineering and Sciences, The University of Texas, Austin, TX.


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