Expensive and lengthy clinical trials can delay regulatory evaluation and add significant burden that stifles innovation affecting patient access to novel, high-quality imaging technologies. In silico imaging holds promise for evaluating the safety and effectiveness of imaging technologies with much less burden than clinical trials. We define in silico imaging as a computer simulation of an entire imaging system (including source, object, task, and observer components) used for research, development, optimization, technology assessment, and regulatory evaluation of new technology. In this work we describe VICTRE (our study of virtual imaging clinical trials for regulatory evaluation) and the considerations for building an entire imaging pipeline in silico including device (physics), patient (anatomy, disease), and image interpretation models for regulatory evaluation using open-source tools.
Aldo Badano, Andreu Badal, Stephen Glick, Christian G. Graff, Frank Samuelson, Diksha Sharma, and Rongping Zeng, "In silico imaging clinical trials for regulatory evaluation: initial considerations for VICTRE, a demonstration study," Proc. SPIE 10132, Medical Imaging 2017: Physics of Medical Imaging, 1013220 (Presented at SPIE Medical Imaging: February 16, 2017; Published: 9 March 2017); https://doi.org/10.1117/12.2255746.
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