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 (Jan , 10.1007/s00330-020-07598-8, 2021)

A Correction to this paper has been published:Radiolog

Dosimetric quantities and effective dose in medical imaging: a summary for medical doctors

This review presents basic information on the dosimetric quantities used in medical imaging for reporting patient doses and establishing diagnostic reference levels. The proper use of the radiation protection quantity “effective dose” to compare doses delivered by different radiological procedures and different imaging modalities with its uncertainties and limitations, is summarised. The estimates of population doses required by the European Directive on Basic Safety Standards is commented on. Referrers and radiologists should be familiar with the dose quantities to inform patients about radiation risks and benefits. The application of effective dose on the cumulative doses from recurrent imaging procedures is also discussed. Patient summary: Basic information on the measurement units (dosimetric quantities) used in medical imaging for reporting radiation doses should be understandable to patients. The Working Group on “Dosimetry for imaging in clinical practice” recommended that a brief explanation on the used dosimetric quantities and units included in the examination imaging report, should be available for patients. The use of the quantity “effective dose” to compare doses to which patients are exposed to from different radiological procedures and its uncertainties and limitations, should also be explained in plain language. This is also relevant for the dialog on to the cumulative doses from recurrent imaging procedures. The paper summarises these concepts, including the need to estimate the population doses required by the European Directive on Basic Safety Standards. Referrers and radiologists should be familiar with the dose quantities to inform patients about radiation risks and benefits

Late adverse reactions to intravascular iodine based contrast media:an update

Radiolog

Validated imaging biomarkers as decision-making tools in clinical trials and routine practice: current status and recommendations from the EIBALL* subcommittee of the European Society of Radiology (ESR)

Observer-driven pattern recognition is the standard for interpretation of medical images. To achieve global parity in interpretation, semi-quantitative scoring systems have been developed based on observer assessments; these are widely used in scoring coronary artery disease, the arthritides and neurological conditions and for indicating the likelihood of malignancy. However, in an era of machine learning and artificial intelligence, it is increasingly desirable that we extract quantitative biomarkers from medical images that inform on disease detection, characterisation, monitoring and assessment of response to treatment. Quantitation has the potential to provide objective decision-support tools in the management pathway of patients. Despite this, the quantitative potential of imaging remains under-exploited because of variability of the measurement, lack of harmonised systems for data acquisition and analysis, and crucially, a paucity of evidence on how such quantitation potentially affects clinical decision-making and patient outcome. This article reviews the current evidence for the use of semi-quantitative and quantitative biomarkers in clinical settings at various stages of the disease pathway including diagnosis, staging and prognosis, as well as predicting and detecting treatment response. It critically appraises current practice and sets out recommendations for using imaging objectively to drive patient management decisions

Standardised lesion segmentation for imaging biomarker quantitation: a consensus recommendation from ESR and EORTC

Background Lesion/tissue segmentation on digital medical images enables biomarker extraction, image-guided therapy delivery, treatment response measurement, and training/validation for developing artificial intelligence algorithms and workflows. To ensure data reproducibility, criteria for standardised segmentation are critical but currently unavailable. Methods A modified Delphi process initiated by the European Imaging Biomarker Alliance (EIBALL) of the European Society of Radiology (ESR) and the European Organisation for Research and Treatment of Cancer (EORTC) Imaging Group was undertaken. Three multidisciplinary task forces addressed modality and image acquisition, segmentation methodology itself, and standards and logistics. Devised survey questions were fed via a facilitator to expert participants. The 58 respondents to Round 1 were invited to participate in Rounds 2-4. Subsequent rounds were informed by responses of previous rounds. Results/conclusions Items with >= 75% consensus are considered a recommendation. These include system performance certification, thresholds for image signal-to-noise, contrast-to-noise and tumour-to-background ratios, spatial resolution, and artefact levels. Direct, iterative, and machine or deep learning reconstruction methods, use of a mixture of CE marked and verified research tools were agreed and use of specified reference standards and validation processes considered essential. Operator training and refreshment were considered mandatory for clinical trials and clinical research. Items with a 60-74% agreement require reporting (site-specific accreditation for clinical research, minimal pixel number within lesion segmented, use of post-reconstruction algorithms, operator training refreshment for clinical practice). Items with <= 60% agreement are outside current recommendations for segmentation (frequency of system performance tests, use of only CE-marked tools, board certification of operators, frequency of operator refresher training). Recommendations by anatomical area are also specified