Imaging biomarker roadmap for cancer studies.

dc.contributor.author

O'Connor, James PB

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Aboagye, Eric O

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Adams, Judith E

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Aerts, Hugo JWL

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Barrington, Sally F

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Beer, Ambros J

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Boellaard, Ronald

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Bohndiek, Sarah E

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Brady, Michael

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Brown, Gina

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Buckley, David L

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Chenevert, Thomas L

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Clarke, Laurence P

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Collette, Sandra

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Cook, Gary J

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deSouza, Nandita M

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Dickson, John C

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Dive, Caroline

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Evelhoch, Jeffrey L

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Faivre-Finn, Corinne

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Gallagher, Ferdia A

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Gilbert, Fiona J

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Gillies, Robert J

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Goh, Vicky

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Griffiths, John R

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Groves, Ashley M

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Halligan, Steve

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Harris, Adrian L

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Hawkes, David J

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Hoekstra, Otto S

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Huang, Erich P

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Hutton, Brian F

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Jackson, Edward F

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Jayson, Gordon C

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Jones, Andrew

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Koh, Dow-Mu

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Lacombe, Denis

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Lambin, Philippe

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Lassau, Nathalie

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Leach, Martin O

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Lee, Ting-Yim

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Leen, Edward L

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Lewis, Jason S

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Liu, Yan

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Lythgoe, Mark F

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Manoharan, Prakash

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Maxwell, Ross J

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Miles, Kenneth A

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Morgan, Bruno

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Morris, Steve

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Ng, Tony

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Padhani, Anwar R

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Parker, Geoff JM

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Partridge, Mike

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Pathak, Arvind P

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Peet, Andrew C

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Punwani, Shonit

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Reynolds, Andrew R

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Robinson, Simon P

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Shankar, Lalitha K

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Sharma, Ricky A

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Soloviev, Dmitry

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Stroobants, Sigrid

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Sullivan, Daniel C

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Taylor, Stuart A

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Tofts, Paul S

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Tozer, Gillian M

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van Herk, Marcel

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Walker-Samuel, Simon

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Wason, James

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Williams, Kaye J

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Workman, Paul

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Yankeelov, Thomas E

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Brindle, Kevin M

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McShane, Lisa M

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Jackson, Alan

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Waterton, John C

dc.date.accessioned

2019-02-01T15:24:18Z

dc.date.available

2019-02-01T15:24:18Z

dc.date.issued

2017-03

dc.date.updated

2019-02-01T15:24:13Z

dc.description.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.

dc.identifier

nrclinonc.2016.162

dc.identifier.issn

1759-4774

dc.identifier.issn

1759-4782

dc.identifier.uri

https://hdl.handle.net/10161/18011

dc.language

eng

dc.publisher

Springer Science and Business Media LLC

dc.relation.ispartof

Nature reviews. Clinical oncology

dc.relation.isversionof

10.1038/nrclinonc.2016.162

dc.subject

Humans

dc.subject

Neoplasms

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Organotechnetium Compounds

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Folic Acid

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Fluorodeoxyglucose F18

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Radiopharmaceuticals

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Positron-Emission Tomography

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Prognosis

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Reproducibility of Results

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Selection Bias

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Research Design

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Cost-Benefit Analysis

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Biomarkers, Tumor

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Clinical Decision-Making

dc.title

Imaging biomarker roadmap for cancer studies.

dc.type

Journal article

duke.contributor.orcid

Sullivan, Daniel C|0000-0002-7556-5650

pubs.begin-page

169

pubs.end-page

186

pubs.issue

3

pubs.organisational-group

School of Medicine

pubs.organisational-group

Duke

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Duke Clinical Research Institute

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Institutes and Centers

pubs.organisational-group

Radiology

pubs.organisational-group

Clinical Science Departments

pubs.publication-status

Published

pubs.volume

14

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