Table 4 Recommendations for the use of quantitative imaging biomarkers as decision-support tools
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 • CaBIG (USA) • 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 |