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Proceedings Paper

In silico imaging clinical trials for regulatory evaluation: initial considerations for VICTRE, a demonstration study
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Paper Abstract

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.

Paper Details

Date Published: 9 March 2017
PDF: 6 pages
Proc. SPIE 10132, Medical Imaging 2017: Physics of Medical Imaging, 1013220 (9 March 2017); doi: 10.1117/12.2255746
Show Author Affiliations
Aldo Badano, U.S. Food and Drug Administration (United States)
Andreu Badal, U.S. Food and Drug Administration (United States)
Stephen Glick, U.S. Food and Drug Administration (United States)
Christian G. Graff, U.S. Food and Drug Administration (United States)
Frank Samuelson, U.S. Food and Drug Administration (United States)
Diksha Sharma, U.S. Food and Drug Administration (United States)
Rongping Zeng, U.S. Food and Drug Administration (United States)


Published in SPIE Proceedings Vol. 10132:
Medical Imaging 2017: Physics of Medical Imaging
Thomas G. Flohr; Joseph Y. Lo; Taly Gilat Schmidt, Editor(s)

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