Gregory V. Goldmacher MD, PhD, Presenter: Employee, ICON plc

1) Understand the key differences between reading radiological studies in clinical practice and clinical trials. 2) Apply common oncological response criteria (such as RECIST, RANO, and the IWG criteria for lymphoma) as examples of structured radiological interpretation in clinical trials. 3) Understand the use of advanced and quantitative imaging methods in early phase trial decision making.

There are significant differences between reading scans in clinical practice and reading for a clinical trial. The focus of the interepretation is not diagnosis, but quantification. The information available to the reader is different, as is the typical handling of incidental findings, and the approach to risk management. There are several types of reads that radiologists may perform, including eligibility, efficacy, and independent confirmation of events (such as disease progression). The read is typically done in a structured manner. There is a variety of formalized rules and criteria for assessing disease severity, and we will discuss illustrative examples. Quantitative imaging is a key component of clinical trial radiology, and we will discuss imaging biomarkers and their applications in trials.

Goldmacher, G, Radiological Interpretation in Therapeutic Trials.  Radiological Society of North America 2014 Scientific Assembly and Annual Meeting, - ,Chicago IL. http://archive.rsna.org/2014/14002208.html