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 & 57 others 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

Research output: Contribution to journalReview articleAcademicpeer-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 languageEnglish
Pages (from-to)169-186
Number of pages18
JournalNature Reviews Clinical Oncology
Volume14
Issue number3
DOIs
Publication statusPublished - Mar 2017

Cite this

O'Connor, J. P. B., Aboagye, E. O., Adams, J. E., Aerts, H. J. W. L., Barrington, S. F., Beer, A. J., ... 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
O'Connor, James P B ; Aboagye, Eric O ; Adams, Judith E ; Aerts, Hugo J W L ; Barrington, Sally F ; Beer, Ambros J ; Boellaard, Ronald ; Bohndiek, Sarah E ; Brady, Michael ; Brown, Gina ; Buckley, David L ; Chenevert, Thomas L ; Clarke, Laurence P ; Collette, Sandra ; Cook, Gary J ; deSouza, Nandita M ; Dickson, John C ; Dive, Caroline ; Evelhoch, Jeffrey L ; Faivre-Finn, Corinne ; Gallagher, Ferdia A ; Gilbert, Fiona J ; Gillies, Robert J ; Goh, Vicky ; Griffiths, John R ; Groves, Ashley M ; Halligan, Steve ; Harris, Adrian L ; Hawkes, David J ; Hoekstra, Otto S ; Huang, Erich P ; Hutton, Brian F ; Jackson, Edward F ; Jayson, Gordon C ; Jones, Andrew ; Koh, Dow-Mu ; Lacombe, Denis ; Lambin, Philippe ; Lassau, Nathalie ; Leach, Martin O ; Lee, Ting-Yim ; Leen, Edward L ; Lewis, Jason S ; Liu, Yan ; Lythgoe, Mark F ; Manoharan, Prakash ; Maxwell, Ross J ; Miles, Kenneth A ; Morgan, Bruno ; Morris, Steve ; Ng, Tony ; Padhani, Anwar R ; Parker, Geoff J M ; Partridge, Mike ; Pathak, Arvind P ; Peet, Andrew C ; Punwani, Shonit ; Reynolds, Andrew R ; Robinson, Simon P ; Shankar, Lalitha K ; Sharma, Ricky A ; Soloviev, Dmitry ; Stroobants, Sigrid ; Sullivan, Daniel C ; Taylor, Stuart A ; Tofts, Paul S ; Tozer, Gillian M ; van Herk, Marcel ; Walker-Samuel, Simon ; Wason, James ; Williams, Kaye J ; Workman, Paul ; Yankeelov, Thomas E ; Brindle, Kevin M ; McShane, Lisa M ; Jackson, Alan ; Waterton, John C. / Imaging biomarker roadmap for cancer studies. In: Nature Reviews Clinical Oncology. 2017 ; Vol. 14, No. 3. pp. 169-186.
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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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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

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

In: Nature Reviews Clinical Oncology, Vol. 14, No. 3, 03.2017, p. 169-186.

Research output: Contribution to journalReview articleAcademicpeer-review

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 - Biomarkers, Tumor

KW - Clinical Decision-Making

KW - Cost-Benefit Analysis

KW - Fluorodeoxyglucose F18

KW - Folic Acid

KW - Humans

KW - Neoplasms

KW - Organotechnetium Compounds

KW - Positron-Emission Tomography

KW - Prognosis

KW - Radiopharmaceuticals

KW - Reproducibility of Results

KW - Research Design

KW - Selection Bias

KW - Consensus Development Conference

KW - Journal Article

KW - Review

U2 - 10.1038/nrclinonc.2016.162

DO - 10.1038/nrclinonc.2016.162

M3 - Review article

VL - 14

SP - 169

EP - 186

JO - Nature Reviews Clinical Oncology

JF - Nature Reviews Clinical Oncology

SN - 1759-4774

IS - 3

ER -

O'Connor JPB, Aboagye EO, Adams JE, Aerts HJWL, Barrington SF, Beer AJ et al. Imaging biomarker roadmap for cancer studies. Nature Reviews Clinical Oncology. 2017 Mar;14(3):169-186. https://doi.org/10.1038/nrclinonc.2016.162