Quantitative imaging biomarkers: a review of statistical methods for technical performance assessment

Area of Science:

• Medical Imaging
• Biomarker Development
• Metrology

Background:

• Increasing interest in quantitative imaging biomarkers for measuring biological features in medical images.
• Technological advancements necessitate rigorous performance evaluation of these biomarkers.
• Current performance studies lack standardization, hindering result integration and study design.

Purpose of the Study:

• To establish a consistent framework for quantitative imaging biomarker performance studies.
• To provide standardized methods, metrics, and study designs for biomarker evaluation.
• To enable comparison, contrast, and combination of results from multiple studies.

Main Methods:

• Development of technical performance analysis methods, metrics, and study designs.
• Inclusion of experts from technical, radiological, and statistical fields.
• Alignment with widely accepted metrological standards for measurement quality.

Main Results:

• A consistent framework for conducting and evaluating quantitative imaging biomarker performance studies.
• Standardized terminology, metrics, and methods for metrological assessment.
• Improved ability to integrate and compare results from diverse studies.

Conclusions:

• The developed framework addresses the need for standardization in quantitative imaging biomarker research.
• Implementation of this framework will enhance the reliability and comparability of biomarker performance data.
• This standardization is crucial for the successful clinical translation and application of imaging biomarkers.