Validating the imaging biomarker: The proof of efficacy and effectiveness

Abstract

Medical imaging is an active and developing area, providing significant anatomical, functional, and molecular information in a wide range of clinical and research studies. Medical imaging techniques like ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET) in conjunction with advanced acquisition protocols have given rise to creating and establishing quantitative biomarkers to assess biological processes and clinical end points [1]. Imaging modalities such as CT, MRI, and PET and their associated imaging biomarkers contribute significantly to the design of oncology therapeutic trials [2]. In contrast to biomarkers obtained by gathering tissue sample from a patient (i.e., genes or proteins from molecular studies), imaging biomarkers have the advantage of being noninvasive, repeatable over time, and relatively comfortable for patients (Table 10.1).