ABSTRACT
This chapter describes the interplay between diagnostic procedures and therapeutic clinical trials. Indeed, diagnostic imaging is a crucial element in the design and conduct of most clinical trials in oncology. For example, diagnostic imaging is present in Phase I trials for safety studies of new therapies, be they chemotherapy, radiotherapy, or biological. In order to monitor the safety and efficacy endpoints of such trials, imaging procedures determine the advance and extent of the disease and produce the primary and secondary endpoints. The chapter introduces the three phases of clinical trials and how imaging plays a role in the conduct of each trial. This is followed by a description of the protocol for clinical trials in oncology and a brief description of the protocol review process at the MD Anderson Cancer Center (MDACC). The RECIST (response evaluation criteria in solid tumors) criteria for response to therapy are introduced. This is a set of guidelines for the radiologists in their determination of the patient’s response to therapy and, hence, on the conclusions for the success or failure of the trial.
