Radiomics in Clinical Trials – The Rationale, Current Practices, and Future Considerations

Radiomics involves deep quantitative analysis of radiological images for structural and/or functional information. – It is a phenomic assessment of disease to understand lesion microstructure, microenvironment and molecular/cellular function. – In oncology, it helps us accurately classify, stratify and prognosticate tumors based on if, how and when they transform, infiltrate, involute or metastasize, – Utilizing radiomics in clinical trials is exploratory, and not an established end-point. – Integrating radiomics in an imaging-based clinical trials involves a streamlined workflow to handle large datasets, robust platforms to accommodate machine learning calculations, and seamless incorporation of derived insights into outcomes matrix.

Reporter Gene Imaging and its Role in Imaging-Based Drug Development.

This abstract presents how RGI can be used in drug development for pharmacodynamic and pharmacokinetic assessment of cellular, gene, oncolytic viral and immunotherapeutic approaches using MRI, PET, SPECT, Ultrasound, Bioluminescence and Fluoroscence.  Some of the teaching points include further insight into RGI imaging probes that can be direct, indirect or activable; range from enzymes, protein receptors and cell membrane transporters and how RGI qualitatively and quantitatively assesses cell targeting, transfection, protein expression and intracellular processes.