AAPM task group 234 report: Virtual tools for the evaluation of new 3D/4D breast imaging systems

Simulation methods in breast imaging offer advantages over clinical trials in terms of improved reproducibility, reduced need for patient exposure to radiation, increased flexibility, and more clearly defined ground truth. Simulation also allows for improved representation of anatomical variations and variations in acquisition parameters and breast positioning related to multimodality imaging. The increasing use of virtual clinical trials (VCTs) to assess breast imaging systems has introduced a demand to optimize protocols for simulation studies. This work will contribute to developing standards for evaluation tools for 3D/4D breast imaging systems and will ultimately reduce the reliance on clinical trials for emerging systems. This report reviews key aspects of VCTs, including the simulation of realistic breast anatomy, the generation of synthetic images from virtual phantoms, the use of model observers to assess imaging system performance, and methods to analyze observer outputs. Each section reviews the state of the science and recommends approaches for accomplishing tasks related to the individual aspects of VCTs. The report also reviews the experience of designing and using a simulation approach from the industrial and regulatory perspective. Finally, future steps in the development of VCTs are suggested. breast cancer imaging, evaluation of imaging systems, virtual trials.