QI-Bench: Optimizing Performance Through Characterization.
Quantitative imaging applications such as imaging biomarkers are developed for use in the clinical care of patients and in the conduct of clinical trials of therapy. In clinical practice, imaging biomarkers are intended to (a) detect and characterize disease, before, during or after a course of therapy, and (b) predict the course of disease, with or without therapy. In clinical research, imaging biomarkers are intended to be used in defining endpoints of clinical trials. A precondition for the adoption of the biomarker for use in either setting is the demonstration of the ability to standardize the biomarker across imaging devices and clinical centers and the assessment of the biomarker's reproducibility.
Although qualitative biomarkers can be useful, the medical community currently emphasizes the need for objective, ideally quantitative, biomarkers. Extracting quantitative data from medical images generally requires a software algorithm. In this grant application, "biomarker" refers to the measurement derived from an imaging method, and "device" or "test" refers to the hardware/software used to generate the image and extract the measurement. Regulatory approval for clinical use and regulatory qualification for research use depend on demonstrating proof of performance relative to the intended application of the biomarker:
- In a defined patient population,
- For a specific biological phenomenon associated with a known disease state,
- With evidence in large patient populations, and
- Externally validated.
In this project, we provide open-source informatics tooling used to characterize the performance of quantitative medical imaging as needed to advance the field. These tools may be deployed internal to an organization or used for collaborative work across organizations. The data on which they work may be accessible only to identified individuals, or more broadly in an open archive, to suit the specific project purpose.