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Nat Rev Clin Oncol. 2017 Mar;14(3):169-186. doi: 10.1038/nrclinonc.2016.162. Epub 2016 Oct 11.

Imaging biomarker roadmap for cancer studies.

Author information

1
CRUK and EPSRC Cancer Imaging Centre in Cambridge and Manchester, University of Manchester, Manchester, UK.
2
Department of Surgery and Cancer, Imperial College, London, UK.
3
Department of Clinical Radiology, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.
4
Department of Radiation Oncology, Harvard Medical School, Boston, MA.
5
CRUK and EPSRC Comprehensive Imaging Centre at KCL and UCL, Kings College London, London, UK.
6
Department of Nuclear Medicine, University Hospital Ulm, Ulm, Germany.
7
Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, Groningen, The Netherlands.
8
CRUK and EPSRC Cancer Imaging Centre in Cambridge and Manchester, University of Cambridge, Cambridge, UK.
9
CRUK and EPSRC Cancer Imaging Centre, University of Oxford, Oxford, UK.
10
Radiology Department, Royal Marsden Hospital, London, UK.
11
Division of Biomedical Imaging, University of Leeds, Leeds, UK.
12
Department of Radiology, University of Michigan, Ann Arbor, MI.
13
Cancer Imaging Program, National Cancer Institute, Bethesda, MD.
14
Biostatistics, EORTC, Brussels, Belgium.
15
CRUK Cancer Imaging Centre, The Institute of Cancer Research, London, UK.
16
CRUK and EPSRC Cancer Imaging Centre at KCL and UCL, University College London, London, UK.
17
Clinical and Experimental Pharmacology, CRUK Manchester Institute, Manchester, UK.
18
Translational Biomarkers, Merck &Co., Inc, West Point, PA.
19
Radiotherapy Related Research Group, University of Manchester, Manchester, UK.
20
Cancer Imaging and Metabolism, Moffitt Cancer Center, Tampa, FL.
21
Department of Radiology and Nuclear Medicine, VU University Medical Centre, Amsterdam, The Netherlands.
22
Biometric Research Program, National Cancer Institute, Bethesda, MD.
23
Department of Medical Physics, University of Wisconsin, Madison, WI.
24
Institute of Cancer Sciences, University of Manchester, Manchester, UK.
25
Medical Physics, The Christie Hospital NHS Foundation Trust, Manchester, UK.
26
EORTC Headquarters, EORTC, Brussels, Belgium.
27
Department of Radiation Oncology, University of Maastricht, Maastricht, Netherlands.
28
Department of Imaging, Gustave Roussy Cancer Campus, Villejuif, France.
29
Imaging Research Labs, Robarts Research Institute, London, Ontario, Canada.
30
Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY.
31
Centre for Advanced Biomedical Imaging, University College London, London, UK.
32
Northern Institute for Cancer Research, Newcastle University, Newcastle, UK.
33
Cancer Studies and Molecular Medicine, University of Leicester, Leicester, UK.
34
Institute of Epidemiology and Health, University College London, London, UK.
35
Paul Strickland Scanner Centre, Mount Vernon Hospital, London, UK.
36
Department of Radiology, The Johns Hopkins University School of Medicine, Baltimore, MD.
37
Institute of Cancer and Genomics, University of Birmingham, Birmingham, UK.
38
Breakthrough Breast Cancer Research Centre, The Institute of Cancer Research, London, UK.
39
Molecular Imaging Center Antwerp, University of Antwerp, Antwerp, Belgium.
40
Department of Radiology, Duke University School of Medicine, Durham, NC.
41
Brighton and Sussex Medical School, University of Sussex, Brighton, UK.
42
Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.
43
MRC Biostatistics Unit, Cambridge, UK.
44
CRUK Cancer Therapeutics Unit, The Institute of Cancer Research, London, UK.
45
Institute of Computational Engineering and Sciences, The University of Texas, Austin, TX.

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.

PMID:
27725679
PMCID:
PMC5378302
DOI:
10.1038/nrclinonc.2016.162
[Indexed for MEDLINE]
Free PMC Article

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