ABSTRACT

Imaging biomarkers are widely used in medicine and have been employed by regulatory agencies as surrogate end points and as CDxs. This section discusses diverse examples of predictive imaging biomarkers, and the technologies to measure them, such as PET, CT, ultrasound, MRI and SPECT. The focus is on predictive imaging biomarkers that have previously been used in regulatory drug approvals, supplemented by additional emerging and investigational examples. Some clinical trial issues are discussed that are unique to imaging biomarkers but not encountered with other biomarker modalities.