Incorporating radiomics into clinical trials: expert consensus endorsed by the European Society of Radiology on considerations for data-driven compared to biologically driven quantitative biomarkers.

Clinical trial Radiology Standardization Statistics and numerical data Validation studies

Journal

European radiology
ISSN: 1432-1084
Titre abrégé: Eur Radiol
Pays: Germany
ID NLM: 9114774

Informations de publication

Date de publication:
Aug 2021
Historique:
received: 14 07 2020
accepted: 03 12 2020
revised: 16 11 2020
pubmed: 26 1 2021
medline: 14 7 2021
entrez: 25 1 2021
Statut: ppublish

Résumé

Existing quantitative imaging biomarkers (QIBs) are associated with known biological tissue characteristics and follow a well-understood path of technical, biological and clinical validation before incorporation into clinical trials. In radiomics, novel data-driven processes extract numerous visually imperceptible statistical features from the imaging data with no a priori assumptions on their correlation with biological processes. The selection of relevant features (radiomic signature) and incorporation into clinical trials therefore requires additional considerations to ensure meaningful imaging endpoints. Also, the number of radiomic features tested means that power calculations would result in sample sizes impossible to achieve within clinical trials. This article examines how the process of standardising and validating data-driven imaging biomarkers differs from those based on biological associations. Radiomic signatures are best developed initially on datasets that represent diversity of acquisition protocols as well as diversity of disease and of normal findings, rather than within clinical trials with standardised and optimised protocols as this would risk the selection of radiomic features being linked to the imaging process rather than the pathology. Normalisation through discretisation and feature harmonisation are essential pre-processing steps. Biological correlation may be performed after the technical and clinical validity of a radiomic signature is established, but is not mandatory. Feature selection may be part of discovery within a radiomics-specific trial or represent exploratory endpoints within an established trial; a previously validated radiomic signature may even be used as a primary/secondary endpoint, particularly if associations are demonstrated with specific biological processes and pathways being targeted within clinical trials. KEY POINTS: • Data-driven processes like radiomics risk false discoveries due to high-dimensionality of the dataset compared to sample size, making adequate diversity of the data, cross-validation and external validation essential to mitigate the risks of spurious associations and overfitting. • Use of radiomic signatures within clinical trials requires multistep standardisation of image acquisition, image analysis and data mining processes. • Biological correlation may be established after clinical validation but is not mandatory.

Identifiants

pubmed: 33492473
doi: 10.1007/s00330-020-07598-8
pii: 10.1007/s00330-020-07598-8
pmc: PMC8270834
doi:

Substances chimiques

Biomarkers 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

6001-6012

Commentaires et corrections

Type : ErratumIn

Informations de copyright

© 2021. The Author(s).

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Auteurs

Laure Fournier (L)

PARCC, INSERM, Radiology Department, AP-HP, Hopital europeen Georges Pompidou, Université de Paris, F-75015, Paris, France.
European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.

Lena Costaridou (L)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
School of Medicine, University of Patras, University Campus, Rio, 26 500, Patras, Greece.

Luc Bidaut (L)

Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.
College of Science, University of Lincoln, Lincoln, LN6 7TS, UK.

Nicolas Michoux (N)

Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.
Department of Radiology, Institut de Recherche Expérimentale et Clinique (IREC), Cliniques Universitaires Saint Luc, Université Catholique de Louvain (UCLouvain), B-1200, Brussels, Belgium.

Frederic E Lecouvet (FE)

Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.
Department of Radiology, Institut de Recherche Expérimentale et Clinique (IREC), Cliniques Universitaires Saint Luc, Université Catholique de Louvain (UCLouvain), B-1200, Brussels, Belgium.

Lioe-Fee de Geus-Oei (LF)

Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.
Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands.
Biomedical Photonic Imaging Group, University of Twente, Enschede, The Netherlands.

Ronald Boellaard (R)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Radiology & Nuclear Medicine, Cancer Centre Amsterdam, Amsterdam University Medical Centers (VU University), Amsterdam, The Netherlands.
Quantitative Imaging Biomarkers Alliance, Radiological Society of North America, Oak Brook, IL, USA.

Daniela E Oprea-Lager (DE)

Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.
Department of Radiology & Nuclear Medicine, Cancer Centre Amsterdam, Amsterdam University Medical Centers (VU University), Amsterdam, The Netherlands.

Nancy A Obuchowski (NA)

Quantitative Imaging Biomarkers Alliance, Radiological Society of North America, Oak Brook, IL, USA.
Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.

Anna Caroli (A)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Biomedical Engineering, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Bergamo, Italy.

Wolfgang G Kunz (WG)

Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.
Department of Radiology, University Hospital, LMU Munich, Munich, Germany.

Edwin H Oei (EH)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Radiology & Nuclear Medicine, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.

James P B O'Connor (JPB)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Division of Cancer Sciences, University of Manchester, Manchester, UK.

Marius E Mayerhoefer (ME)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria.

Manuela Franca (M)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Radiology, Centro Hospitalar Universitário do Porto, Instituto de Ciências Biomédicas de Abel Salazar, University of Porto, Porto, Portugal.

Angel Alberich-Bayarri (A)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Quantitative Imaging Biomarkers in Medicine (QUIBIM), Valencia, Spain.

Christophe M Deroose (CM)

Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.
Nuclear Medicine, University Hospitals Leuven, Leuven, Belgium.
Nuclear Medicine and Molecular Imaging, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium.

Christian Loewe (C)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Division of Cardiovascular and Interventional Radiology, Dept. for Bioimaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.

Rashindra Manniesing (R)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Radiology and Nuclear Medicine, Radboud University Medical Center, 6525 GA, Nijmegen, The Netherlands.

Caroline Caramella (C)

Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.
Radiology Department, Hôpital Marie Lannelongue, Institut d'Oncologie Thoracique, Université Paris-Saclay, Le Plessis-Robinson, France.

Egesta Lopci (E)

Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.
Nuclear Medicine, Humanitas Clinical and Research Hospital - IRCCS, Rozzano, MI, Italy.

Nathalie Lassau (N)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.
Quantitative Imaging Biomarkers Alliance, Radiological Society of North America, Oak Brook, IL, USA.
Imaging Department, Gustave Roussy Cancer Campus Grand, Paris, UMR 1281, INSERM, CNRS, CEA, Universite Paris-Saclay, Saint-Aubin, France.

Anders Persson (A)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Radiology, and Department of Health, Medicine and Caring Sciences, Center for Medical Image Science and Visualization (CMIV), Linköping University, Linköping, Sweden.

Rik Achten (R)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Radiology and Medical Imaging, Ghent University Hospital, Gent, Belgium.

Karen Rosendahl (K)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Radiology, University Hospital of North Norway, Tromsø, Norway.

Olivier Clement (O)

PARCC, INSERM, Radiology Department, AP-HP, Hopital europeen Georges Pompidou, Université de Paris, F-75015, Paris, France.
European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.

Elmar Kotter (E)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Radiology, University Medical Center Freiburg, Freiburg, Germany.

Xavier Golay (X)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Quantitative Imaging Biomarkers Alliance, Radiological Society of North America, Oak Brook, IL, USA.
Queen Square Institute of Neurology, University College London, London, UK.

Marion Smits (M)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium.
Department of Radiology & Nuclear Medicine, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.

Marc Dewey (M)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Radiology, Charité Universitätsmedizin Berlin, Berlin, Germany.

Daniel C Sullivan (DC)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Quantitative Imaging Biomarkers Alliance, Radiological Society of North America, Oak Brook, IL, USA.
Dept. of Radiology, Duke University, 311 Research Dr, Durham, NC, 27710, USA.

Aad van der Lugt (A)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria.
Department of Radiology & Nuclear Medicine, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.

Nandita M deSouza (NM)

European Imaging Biomarkers Alliance (EIBALL), European Society of Radiology, Vienna, Austria. nandita.deSouza@icr.ac.uk.
Imaging Group, European Organisation of Research and Treatment in Cancer (EORTC), Brussels, Belgium. nandita.deSouza@icr.ac.uk.
Quantitative Imaging Biomarkers Alliance, Radiological Society of North America, Oak Brook, IL, USA. nandita.deSouza@icr.ac.uk.
Division of Radiotherapy and Imaging, The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London, UK. nandita.deSouza@icr.ac.uk.
, Am Gestade 1, 1010, Vienna, Austria.

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