Imaging biomarker roadmap for cancer studies

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; Andrew C. Peet; 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

doi:10.1038/nrclinonc.2016.162

Imaging biomarker roadmap for cancer studies

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-FinnFerdia 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, Andrew C. Peet, 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

^*Corresponding author for this work

Research output: Contribution to journal › (Systematic) Review article › peer-review

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.

Original language	English
Pages (from-to)	169-186
Number of pages	18
Journal	Nature Reviews Clinical Oncology
Volume	14
Issue number	3
DOIs	https://doi.org/10.1038/nrclinonc.2016.162
Publication status	Published - Mar 2017

Keywords

CONTRAST-ENHANCED MRI
POSITRON-EMISSION-TOMOGRAPHY
CELL LUNG-CANCER
GROUP DEVELOPMENTAL PATHWAY
ADVANCED SOLID TUMORS
SURROGATE END-POINTS
HIGH FAMILIAL RISK
DRUG DEVELOPMENT
CLINICAL-TRIALS
BREAST-CANCER

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O'Connor, J. P. B., Aboagye, E. O., Adams, J. E., Aerts, H. J. W. L., 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., ... Waterton, J. C. (2017). Imaging biomarker roadmap for cancer studies. Nature Reviews Clinical Oncology, 14(3), 169-186. https://doi.org/10.1038/nrclinonc.2016.162

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title = "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.",

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

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doi = "10.1038/nrclinonc.2016.162",

language = "English",

volume = "14",

pages = "169--186",

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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 2017, 'Imaging biomarker roadmap for cancer studies', Nature Reviews Clinical Oncology, vol. 14, no. 3, pp. 169-186. https://doi.org/10.1038/nrclinonc.2016.162

TY - JOUR

T1 - Imaging biomarker roadmap for cancer studies

AU - O'Connor, James P. B.

AU - Aboagye, Eric O.

AU - Adams, Judith E.

AU - Aerts, Hugo J. W. L.

AU - Barrington, Sally F.

AU - Beer, Ambros J.

AU - Boellaard, Ronald

AU - Bohndiek, Sarah E.

AU - Brady, Michael

AU - Brown, Gina

AU - Buckley, David L.

AU - Chenevert, Thomas L.

AU - Clarke, Laurence P.

AU - Collette, Sandra

AU - Cook, Gary J.

AU - Desouza, Nandita M.

AU - Dickson, John C.

AU - Dive, Caroline

AU - Evelhoch, Jeffrey L.

AU - Faivre-Finn, Corinne

AU - Gallagher, Ferdia A.

AU - Gilbert, Fiona J.

AU - Gillies, Robert J.

AU - Goh, Vicky

AU - Griffiths, John R.

AU - Groves, Ashley M.

AU - Halligan, Steve

AU - Harris, Adrian L.

AU - Hawkes, David J.

AU - Hoekstra, Otto S.

AU - Huang, Erich P.

AU - Hutton, Brian F.

AU - Jackson, Edward F.

AU - Jayson, Gordon C.

AU - Jones, Andrew

AU - Koh, Dow-Mu

AU - Lacombe, Denis

AU - Lambin, Philippe

AU - Lassau, Nathalie

AU - Leach, Martin O.

AU - Lee, Ting-Yim

AU - Leen, Edward L.

AU - Lewis, Jason S.

AU - Liu, Yan

AU - Lythgoe, Mark F.

AU - Manoharan, Prakash

AU - Maxwell, Ross J.

AU - Miles, Kenneth A.

AU - Morgan, Bruno

AU - Morris, Steve

AU - Ng, Tony

AU - Padhani, Anwar R.

AU - Parker, Geoff J. M.

AU - Partridge, Mike

AU - Pathak, Arvind P.

AU - Peet, Andrew C.

AU - Punwani, Shonit

AU - Reynolds, Andrew R.

AU - Robinson, Simon P.

AU - Shankar, Lalitha K.

AU - Sharma, Ricky A.

AU - Soloviev, Dmitry

AU - Stroobants, Sigrid

AU - Sullivan, Daniel C.

AU - Taylor, Stuart A.

AU - Tofts, Paul S.

AU - Tozer, Gillian M.

AU - van Herk, Marcel

AU - Walker-Samuel, Simon

AU - Wason, James

AU - Williams, Kaye J.

AU - Workman, Paul

AU - Yankeelov, Thomas E.

AU - Brindle, Kevin M.

AU - McShane, Lisa M.

AU - Jackson, Alan

AU - Waterton, John C.

PY - 2017/3

Y1 - 2017/3

N2 - 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.

AB - 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.

KW - CONTRAST-ENHANCED MRI

KW - POSITRON-EMISSION-TOMOGRAPHY

KW - CELL LUNG-CANCER

KW - GROUP DEVELOPMENTAL PATHWAY

KW - ADVANCED SOLID TUMORS

KW - SURROGATE END-POINTS

KW - HIGH FAMILIAL RISK

KW - DRUG DEVELOPMENT

KW - CLINICAL-TRIALS

KW - BREAST-CANCER

U2 - 10.1038/nrclinonc.2016.162

DO - 10.1038/nrclinonc.2016.162

M3 - (Systematic) Review article

C2 - 27725679

SN - 1759-4774

VL - 14

SP - 169

EP - 186

JO - Nature Reviews Clinical Oncology

JF - Nature Reviews Clinical Oncology

IS - 3

ER -