What makes a measurement an imaging biomarker
In short: A biomarker is a defined characteristic measured as an indicator of a biological process, disease or response. Imaging biomarkers need technical and clinical validation.
Categories
The FDA–NIH BEST glossary sorts biomarkers by use: susceptibility or risk, diagnostic, monitoring, prognostic, predictive, pharmacodynamic or response, and safety. The same measurement can serve different uses, and each use needs its own evidence.
Validation in layers
- Technical validation: is the measurement repeatable and reproducible across scanners and sites?
- Clinical validation: does it relate to the clinical quantity of interest in the intended population?
- Utility: does using it improve decisions or outcomes?
Standardisation efforts
Groups such as the RSNA Quantitative Imaging Biomarkers Alliance write profiles that specify how to acquire and measure a biomarker so that values can be compared.
- Show biomarker definitions, reporting systems and related trials
- Interpret a biomarker value for anyone
Read more at the source
- BEST (Biomarkers, EndpointS, and other Tools) resource (opens in a new tab)
- RSNA QIBA (opens in a new tab)
Glossary: Imaging biomarker, Quantitative imaging biomarker, Test-retest repeatability
This lesson is general education. It does not interpret anyone’s images, results or treatment, and it is not medical advice.