MRI Standardization for Quantitative Disease Biomarkers: implementation to clinical studies and trials

Magnetic Resonance Imaging (MRI) offers a natural, quantitative way of characterizing soft tissues in health and disease. With the development of the MRI field, the quantitative aspect was dropped in favor of qualitative, contrast-based imaging approaches. In recent years a renewed interest in quantitation in MRI has emerged, enabled by the development of new ideas for shortening the length of qMRI scans rivaling contrast-based approaches. The absolute categorization of tissue is based on quantitative biomarkers established in clinical studies and trials. The major biomarkers are based on MR tissue properties - longitudinal T1 and transverse T2 relaxation times, diffusion properties – Apparent Diffusion Coefficient (ADC), etc. A significant obstacle in adopting clinical qMRI methodologies is the variability of the quantitative output within and across manufacturers. CaliberMRI (CMRI) is on a quest to standardize scanner lateral and longitudinal performance using quantitative Reference MRI Mimics. The mimics are standardized by the NIST and qCal, a CMRI software platform for comprehensive QA/QC analysis. We will present a use case of standardization of ADC as a breast cancer biomarker in neoadjuvant therapy monitoring in I-SPY2 clinical trial.