Imaging in antiangiogenesis trial: a clinical trials radiology perspective.
Traditional approaches for treating cancer have largely focused on the ability of chemotherapy, and to a lesser extent radiation therapy, to destroy tumour cells. Recent developments in antiangiogenesis treatments require a fundamental shift in the radiological and imaging paradigms associated with evaluating response. Proper design and execution of any clinical trial involving imaging angiogenesis requires satisfactory consideration of a number of strategies and an in-depth understanding of different imaging techniques such as dynamic contrast enhanced MRI and CT, contrast-enhanced ultrasound and positron emission tomography. In particular, for imaging, the strategies can be divided into issues that need to be addressed during the protocol planning phase, and strategies that need to be addressed during the execution phase. Furthermore, clinical trials are usually subject to stringent regulations surrounding traceability and reproducibility that need to be followed before the regulatory authorities will accept the integrity of the data. This paper elaborates on the above strategies and outlines certain aspects, or tactics, that need to be considered while preparing for a multicentre clinical trial that involves imaging angiogenesis.