| Variable | Definición |
|---|---|
| Imaging biomarker name | The imaging characteristic derived from one or more images and objectively measured according to a ratio or interval scale as an indicator of normal biological processes, pathogenic processes, response to a therapeutic intervention, or clinical endpoint. [1] |
| Surrogation | A measurement or pathological sign that serves as a clinically meaningful endpoint, reflecting how a patient feels, functions, or survives, and is expected to predict disease behavior, therapeutic effects, or other true clinical outcomes. [2] |
| Clinical relevance | An explanation of the imaging biomarker’s biological significance, including its relevance to clinical outcomes or decision-making, either generally or for specific conditions. |
| Main target | Aggregated as: diagnostic, prognostic, predictive. |
| Organ(s) | Anatomical region(s) to which the imaging biomarker applies or is validated. |
| Disease / Substrate | The specific pathological condition or abnormality associated with the imaging biomarker. |
| Image modality | The imaging technology used to capture images at various structural scales and functional levels. [3] |
| Acquisition technique | A specific set of parameters or settings used to acquire an image or a related series of images. |
| Technical parameters | Acquisition and processing conditions necessary for valid and reproducible biomarker estimation. |
| Extraction | Method or algorithm used to calculate a quantitative parameter from an image or a series of images. |
| Association type | Describes whether the biomarker value is derived through a predefined and reproducible mathematical model or inferred through adaptive methods such as statistical learning or AI models. The possible values are deterministic or estimative. |
| Dimensionality | Describes whether the biomarker value is derived from a single imaging parameter or from the combination of multiple imaging-derived inputs (imaging biomarker signature) or multimodal (combined with non-imaging data). The possible values are single or composite. |
| Units | Standard measurement scale. |
| Range(s) | Threshold intervals that characterize or separate classes within a population, according to the specific clinical question and organ being addressed. |
| Actionability | Defines and justifies a specific clinical decision action related to the result on the biomarker. |
| Endorsed by publications | The scientific support for the imaging biomarker, expressed as evidence levels [4], based on no more than six publications. |
| Endorsed by professional societies | Name of the main scientific/medical societies, not more than three, that formally recognized the imaging biomarker. |
| Regulatory qualifications | The imaging biomarker implementation falls under the scope of the EU MDR and/or USA FDA. |
| Repository | Link to the specific platform with the main code if accessible. |
| Version/author | Value assigned to track changes of the catalogue content and the responsible author(s). |
Leyenda:
Core identification
Clinical context
Validation
Imaging and technical information
Administrative data