ESR Statement on the Validation of Imaging Biomarkers

AbstractMedical imaging capable of generating imaging biomarkers, specifically radiology and nuclear medicine image acquisition and analysis processes, differs from frequently used comparators like blood or urine biomarkers. This difference arises from the  sample acquisition methodology. While different analysis methodologies and equipment provide slightly different results in any analytical domain, unlike blood or urine analysis where the samples are obtained by simple extraction or excretion, in radiology the acquisition of the sample is heterogen eous by design, since complex equipment from different vendors is used. Therefore, with this additional degree of freedom in medical imaging, there is still risk of persistent heterogeneity of image quality through time, due to different technological implementations across vendors and protocols use d in different centres. Quantitative imaging biomarkers have yet to demonstrate an impact on clinical practice due to this lack of comprehensive standardisation in terms of technical aspects of image acquisition, analysis algorithms, processes and clinical validation.The aim is establishing a standard methodology based on metrology for the validation of image acquisition and analysis methods used in the extraction of biomarkers and radiomics data. The appropriate implementation of the guidelines herein proposed by radiology departments, research institutes and industry will allow for a significant reduction in inter-vendor& inter...
Source: Insights into Imaging - Category: Radiology Source Type: research