Imaging biomarker roadmap for cancer studies.

Journal Article (Journal Article;Review)

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.

Full Text

Duke Authors

Cited Authors

  • O'Connor, JPB; Aboagye, EO; Adams, JE; Aerts, HJWL; Barrington, SF; Beer, AJ; Boellaard, R; Bohndiek, SE; Brady, M; Brown, G; Buckley, DL; 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

Published Date

  • March 2017

Published In

Volume / Issue

  • 14 / 3

Start / End Page

  • 169 - 186

PubMed ID

  • 27725679

Pubmed Central ID

  • PMC5378302

Electronic International Standard Serial Number (EISSN)

  • 1759-4782

Digital Object Identifier (DOI)

  • 10.1038/nrclinonc.2016.162


  • eng

Conference Location

  • England