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Table 4 Recommendations for the use of quantitative imaging biomarkers as decision-support tools

From: 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)

Recommendation Current evidence Action needed
Consider need for quantitation in relation to the decision being made Semi-quantitative imaging biomarkers are successfully used in many clinical pathways. • Classification systems retain a subjective element that could benefit from standardisation and refinement.
• Development of automated and thresholding would enable more quantitative assessments
Use validated IB methodology for semi-quantitative and quantitative measures Many single and multicentre trials validating quantitative imaging biomarkers with clinical outcome now exist. • Harmonisation of methodology
• Standardised reporting systems
Establish evidence on the use of quantitation by inclusion into clinical trials Clinical trials are usually planned by non-imagers. Integration of imaging biomarkers into trials is dependent on what is available routinely to non-imagers in the clinic, rather than exploiting an imaging technique to its optimal potential. • Inventory of imaging biomarkers accessible through a web-based portal would inform the inclusion and utilisation of imaging biomarkers within trials (The European Imaging Biomarkers Alliance initiative).
• Certified biomarkers conforming to set standards (Quantitative Imaging Biomarkers Alliance initiative)
Validate against pathology or clinical outcomes to make imaging a “virtual biopsy” Several major databanks hold imaging and clinical or pathology data
• UK MRC Biobank (UK)
• German National Cohort Study (Germany)
• Large data collection for validation of imaging and pathology
• Curation in imaging biobanks
Select appropriate quality assured quantitative IB Trials with embedded QA/QC procedures have indicated good reproducibility of quantitative imaging biomarkers (e.g. EU iMi QuIC:ConCePT project) • Ensure curation and archiving of longitudinal imaging data with outcomes within trials
Open-source interchange kernel Low comparability between image-derived biomarkers if hardware and software of different manufacturers are used. • Harmonisation of image acquisition and post-processing over manufacturers