Virtual clinical trials (VCTs) can be used to evaluate and optimise medical imaging systems. VCTs are based on computer simulations of human anatomy, imaging modalities and image interpretation. OpenVCT is an open-source framework for conducting VCTs of medical imaging, with a particular focus on breast imaging. The aim of this paper was to evaluate the OpenVCT framework in two tasks involving digital breast tomosynthesis (DBT). First, VCTs were used to perform a detailed comparison of virtual and clinical reading studies for the detection of lesions in digital mammography and DBT. Then, the framework was expanded to include mechanical imaging (MI) and was used to optimise the novel combination of simultaneous DBT and MI. The first experiments showed close agreement between the clinical and the virtual study, confirming that VCTs can predict changes in performance of DBT accurately. Work in simultaneous DBT and MI system has demonstrated that the system can be optimised in terms of the DBT image quality. We are currently working to expand the OpenVCT software to simulate MI acquisition more accurately and to include models of tumour growth. Based on our experience to date, we envision a future in which VCTs have an important role in medical imaging, including support for more imaging modalities, use with rare diseases and a role in training and testing artificial intelligence (AI) systems.

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. Purpose Malignant breast lesions can be distinguished from benign lesions by their mechanical properties. This has been utilized for mechanical imaging in which the stress distribution over the breast is measured. Mechanical imaging has shown the ability to identify benign or normal cases and to reduce the number of false positives from mammography screening. Our aim was to develop a model of mechanical imaging acquisition for simulation purposes. To that end, we simulated mammographic compression of a computer model of breast anatomy and lesions. Approach The breast compression was modeled using the finite element method. Two finite element breast models of different sizes were used and solved using linear elastic material properties in open-source virtual clinical trial (VCT) software. A spherical lesion (15 mm in diameter) was inserted into the breasts, and both the location and stiffness of the lesion were varied extensively. The average stress over the breast and the average stress at the lesion location, as well as the relative mean pressure over lesion area (RMPA), were calculated. Results The average stress varied 6.2–6.5 kPa over the breast surface and 7.8–11.4 kPa over the lesion, for different lesion locations and stiffnesses. These stresses correspond to an RMPA of 0.80 to 1.46. The average stress was 20% to 50% higher at the lesion location compared with the average stress over the entire breast surface. Conclusions The average stress over the breast and the lesion location corresponded well to clinical measurements. The proposed model can be used in VCTs for evaluation and optimization of mechanical imaging screening strategies.