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Objective: Nowadays, in Bulgaria there is a trend of increasing entry into the surgical field of robot-assisted surgery operations, which suggests a need for the establishment of a large number of specialists in this field in a short period. Based on these arguments, the Medical University of Varna was the first university in the country to introduce a robotic surgery training program for medical students. The study aims to investigate the medical students’ satisfaction on robotic surgery training provided at Medical University of Varna with da Vinci Skills Simulator. Design: During the summer semester of the academic 2020/2021 and 2021/2022 years, a pilot training of robotic surgery was conducted with 5th year students in Medicine. Within one month, the students had the opportunity to get acquainted with the simulator of da Vinci Xi robotic system. The training was divided into two modules: a two-week theoretical module and a two-week practical module. After completing the training, students filled out a questionnaire dedicated to assess their satisfaction with the proposed training. Correlation between their responses and the objective parameters assessed on the simulator was calculated. Results: Thirty participants (16 men and 14 women) shared their opinion on easiness of use and usefulness of the robotic simulator in training of surgery activities. Students’ responses highly evaluated both aspects with average five-point Likert scale scores of 4.3 and 4.5, respectively. 93% of the participants would continue their further education and training in robotic surgery field. In addition, there was no correlation between objective evaluation by the simulator and students responses. Conclusions: Training in robotic surgery proves to be a useful approach for training students to develop skills and profession in the field of surgery. The results suggest that training in this field may be accomplished even at the student level, by exploiting the robotic surgery in realistic scenario and thus, in a timely manner to find out the surgical direction they want to be further evolved.

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3D breast modelling for 2D and 3D breast x-ray imaging would benefit from the availability of digital and physical phantoms that reproduce accurately the complexity of the breast anatomy. While a number of groups have produced digital phantoms with increasing level of complexity, physical phantoms reproducing that software approach have been scarcely developed. One possibility is offered by 3D printing technology. This implies the assessment of the energy dependent absorption index β of 3D printing materials for absorption based imaging, as well as the assessment of the refractive index decrement, δ, of the printing material, for phase contrast imaging studies, at the energies of interest for breast imaging. In this work we set-up a procedure and performed a series of measurements (at 30, 45 and 60 keV, at the European Synchrotron Radiation Facility) for assessing the relative value of δ with respect to that of breast tissues, for twelve 3D printing materials. The method included propagation based phase contrast 2D imaging and retrieval of the estimated phase shift map, using the Paganin’s algorithm. Breast glandular, adipose and skin tissues were used as reference materials of known ratio δ/β. A percentage difference Δδ was introduced to assess the suitability of the printing materials as tissue substitutes. The accuracy of the method (about 4%) was assessed based on the properties of PMMA and Nylon, acting as gold standard. Results show that, for the above photon energies, ABS is a good substitute for adipose tissue, Hybrid as a substitute of the glandular tissue and PET-G for simulating the skin. We plan to realize a breast phantom manufactured by fused deposition modelling (FDM) technology using ABS, Hybrid and PET-G as substitutes of the glandular and skin tissue and a second phantom by stereolithography (SLA) technology with the resins Flex, Tough and Black. [ABSTRACT FROM AUTHOR]

Clinical studies performed using computer simulation are inexpensive, flexible methods that can be used to study aspects of a proposed imaging technique prior to a full clinical study. Typically, lesions are simulated into (experimental) data to assess the clinical potential of new methods or algorithms. In grating-based phase-contrast imaging (GB-PCI), full wave simulations are, however, computationally expensive due to the high periodicity of the gratings and therefore not practically applicable when large data sets are required. This work describes the development of a hybrid modelling platform that combines analytical and empirical input data for a more rapid simulation of GB-PCI images with little loss of accuracy. Instead of an explicit implementation of grating details, measured summary metrics (i.e. visibility, flux, noise power spectra, presampling modulation transfer function) are applied in order to generate transmission and differential phase images with large fields of view. Realistic transmission and differential phase images were obtained with good quantitative accuracy. The different steps of the simulation framework, as well as the methods to measure the summary metrics, are discussed in detail such that the technique can be easily customized for a given system. The platform offers a fast, accurate alternative to full wave simulations when the focus switches from grating/system design and set up to the generation of GB-PCI images for an established system. [ABSTRACT FROM AUTHOR]

The aim of this work was the evaluation of the software BreastSimulator, a breast x-ray imaging simulation software, as a tool for the creation of 3D uncompressed breast digital models and for the simulation and the optimization of computed tomography (CT) scanners dedicated to the breast. Eight 3D digital breast phantoms were created with glandular fractions in the range 10%–35%. The models are characterised by different sizes and modelled realistic anatomical features. X-ray CT projections were simulated for a dedicated cone-beam CT scanner and reconstructed with the FDK algorithm. X-ray projection images were simulated for 5 mono-energetic (27, 32, 35, 43 and 51 keV) and 3 poly-energetic x-ray spectra typically employed in current CT scanners dedicated to the breast (49, 60, or 80 kVp). Clinical CT images acquired from two different clinical breast CT scanners were used for comparison purposes. The quantitative evaluation included calculation of the power-law exponent, β, from simulated and real breast tomograms, based on the power spectrum fitted with a function of the spatial frequency, f, of the form S(f)  =  α/f  β. The breast models were validated by comparison against clinical breast CT and published data. We found that the calculated β coefficients were close to that of clinical CT data from a dedicated breast CT scanner and reported data in the literature. In evaluating the software package BreastSimulator to generate breast models suitable for use with breast CT imaging, we found that the breast phantoms produced with the software tool can reproduce the anatomical structure of real breasts, as evaluated by calculating the β exponent from the power spectral analysis of simulated images. As such, this research tool might contribute considerably to the further development, testing and optimisation of breast CT imaging techniques. [ABSTRACT FROM AUTHOR]

The major objective is to adopt, apply and test developed in-house algorithms for volumetric breast reconstructions from projection images, obtained in in-line phase-contrast mode. Four angular sets, each consisting of 17 projection images obtained from four physical phantoms, were acquired at beamline ID17, European Synchroton Radiation Facility, Grenoble, France. The tomosynthesis arc was  ±32°. The physical phantoms differed in complexity of texture and introduced features of interest. Three of the used phantoms were in-house developed, and made of epoxy resin, polymethyl-methacrylate and paraffin wax, while the fourth phantom was the CIRS BR3D. The projection images had a pixel size of 47 µm  ×  47 µm. Tomosynthesis images were reconstructed with standard shift-and-add (SAA) and filtered backprojection (FBP) algorithms. It was found that the edge enhancement observed in planar x-ray images is preserved in tomosynthesis images from both phantoms with homogeneous and highly heterogeneous backgrounds. In case of BR3D, it was found that features not visible in the planar case were well outlined in the tomosynthesis slices. In addition, the edge enhancement index calculated for features of interest was found to be much higher in tomosynthesis images reconstructed with FBP than in planar images and tomosynthesis images reconstructed with SAA. The comparison between images reconstructed by the two reconstruction algorithms shows an advantage for the FBP method in terms of better edge enhancement. Phase-contrast breast tomosynthesis realized in in-line mode benefits the detection of suspicious areas in mammography images by adding the edge enhancement effect to the reconstructed slices. [ABSTRACT FROM AUTHOR]

Background: The rapid advancement of medical technologies presents significant challenges for researchers and practitioners. While traditional clinical trials remain the gold standard, they are often limited by high costs, lengthy durations, and ethical constraints. In contrast, in-silico trials and digital twins have emerged not only as efficient and ethical alternatives but also as a complementary technology that can extend beyond classical trials to predict and design new strategies. The successful application of digital twins in industries like nuclear energy, automotive engineering, and aviation underscores their potential in human health., Methods: In April 2024, Duke University hosted the first international summit on Virtual Imaging Trials in Medicine (VITM). The summit brought together over 130 experts from academia, industry, and regulatory bodies to discuss the latest developments, challenges, and future directions in this field. The event featured plenary speakers, presentations, and panel discussions, emphasizing the integration of clinical and in-silico methods to enhance medical evaluations., Results: Key takeaways included the necessity of diverse and realistic digital patient representations, the integration of physics and biology in simulations, and the development of robust validation frameworks. The summit also highlighted the importance of regulatory science and the establishment of Good Simulation Practices to ensure the credibility and reliability of virtual trials., Conclusion: The key discussions and insights from the VITM summit underscore the potential of in-silico trials to revolutionize medical research and patient care through personalized, efficient, and ethical evaluation methods. The collaborative efforts and recommendations from this summit aim to drive future advancements in virtual imaging trials in medicine., (© 2024 American Association of Physicists in Medicine.)

Background: Diabetic retinopathy (DR) is a leading cause of visual impairment globally among working-aged individuals. This study aims to update data on DR prevalence in Bulgaria., Methods: The present cross-sectional study was conducted between 1 January 2022 and 1 January 2023, using a local diabetes registry from the city of Varna as a sampling framework. In total, 587 diabetic patients underwent DR examination. Data included demographics, diabetes type/duration, treatment, and ophthalmic history. DR status was assessed using indirect slit-lamp biomicroscopy or digital fundus photography, graded by the International Clinical Diabetic Retinopathy Scale., Results: Of 587 participants, 13 were excluded due to cataract-related ungradable images. The median age was 65 years (IQR 56-73), with a slight female predominance (54%). The overall prevalence of any DR was 39.9% (95% CI 35.9-44.0), with non-proliferative DR (NPDR) at 27.5%, proliferative DR (PDR) at 7.3%, and macular edema (DME) at 5%. Type 1 diabetes patients had significantly higher DR prevalence (68.8%) than type 2 (34.1%, p < 0.001). Men exhibited higher DR prevalence. Age and diabetes duration correlated positively with DR prevalence. Insulin treatment was associated with higher DR prevalence (55.6%) than oral antidiabetic treatment (22.5%, p < 0.001) for type 2 diabetes patients. Among those diagnosed with DR, 70.9% received treatment, mainly laser therapy., Conclusions: These findings provide epidemiological insights for future research and emphasize the need for a comprehensive national DR screening program in Bulgaria. Technological advancements enable proactive measures to mitigate DR-related visual impairment and blindness, including widespread screening, even in rural areas.

This study investigates the feasibility of employing an in-house-developed physical phantom dedicated to the weekly quality control testing of radiographic systems, performed by radiographers. For this purpose, a 3D phantom was fabricated, featuring test objects, including a model representing a lesion. Alongside this phantom, a commercial phantom, specifically, IBA's Primus L, was utilized. Weekly imaging of both phantoms was conducted over a span of four weeks, involving different imaging protocols and anode voltages. Subsequently, the obtained data underwent visual evaluation, as well as measurement of the intensity of selected regions of interest. The average values for three incident kilovoltages remained consistently stable over the four weeks, with the exception of the "low energy" case, which exhibited variability during the first week of measurements. Following experiments in "Week 1", the X-Ray unit was identified as malfunctioning and underwent necessary repairs. The in-house-developed phantom demonstrated its utility in assessing the performance of the X-Ray system.

This submission comprises the proceedings of the 1st Virtual Imaging Trials in Medicine conference, organized by Duke University on April 22-24, 2024. The listed authors serve as the program directors for this conference. The VITM conference is a pioneering summit uniting experts from academia, industry and government in the fields of medical imaging and therapy to explore the transformative potential of in silico virtual trials and digital twins in revolutionizing healthcare. The proceedings are categorized by the respective days of the conference: Monday presentations, Tuesday presentations, Wednesday presentations, followed by the abstracts for the posters presented on Monday and Tuesday.

Background: Contrast-enhanced mammography is one of the new emerging imaging techniques used for detecting breast tissue lesions. Optimization of imaging protocols and reconstruction techniques for this modality, however, requires the involvement of physical phantoms. Their development is related to the use of radiocontrast agents. This study assesses the X-ray properties of a novel contrast material in clinical settings. This material is intended for experimental use with physical phantoms, offering an alternative to commonly available radiocontrast agents., Materials and Methods: The water-soluble sodium salt of the newly synthesized diiodine-substituted natural eudesmic acid, Sodium 2,6-DiIodo-3,4,5-TriMethoxyBenzoate [NaDITMB], has been investigated with respect to one of the most commonly applied radiocontrast medium in medical practice-Omnipaque ® . For this purpose, simulation and experimental studies were carried out with a computational phantom and a physical counterpart, respectively. Synthetic and experimental X-ray images were subsequently produced under varying beam kilovoltage peaks (kVps), and the proposed contrast material was evaluated., Results and Discussion: Simulation results revealed equivalent absorptions between the two simulated radiocontrast agents. Experimental findings supported these simulations, showing a maximum deviation of 3.7% between the image gray values of contrast materials for NaDITMB and Omnipaque solutions for a 46 kVp X-ray beam. Higher kVp X-ray beams show even smaller deviations in the mean grey values of the imaged contrast agents, with the NaDITMB solution demonstrating less than a 2% deviation compared to Omnipaque., Conclusion: The proposed contrast agent is a suitable candidate for use in experimental work related to contrast-enhanced imaging by utilizing phantoms. It boasts the advantages of easy synthesis and is recognized for its safety, ensuring a secure environment for both the experimenter and the environment.

The effectiveness of modern medical education largely depends on the integration and utilization of digital technologies in teaching various disciplines. In this pilot usability study, we introduced 3D printed anthropomorphic dental models, specifically designed for the elective discipline "Digital and Metal-Free Techniques in Dental Technology" from the curriculum of the Dental Technician specialty in the Medical University of Varna. The evaluation focused on dental technician students' perception of this novel learning environment, its influence on their performance, and the potential for future application of these models and related 3D technologies in their professional practice. A validated satisfaction questionnaire was distributed among 80 students, comprising the total cohort. The results indicated a high acceptance rate, with nearly 95% of participants finding the use of digitally created 3D-printed dental models beneficial. More than 90% believed that exploring digital technologies would enhance their skills. The well-trained instructor's competence in technology use convinced students of its value, with more than 98% expressing a willingness to incorporate these technologies into their future work for improved precision in dental models. However, due to the current high cost of needed equipment, only 10% of participants may practicably introduce this novel technology into their practical work. The use of anatomically accurate 3D printed models is a valuable addition to the current dental technician curriculum in medical colleges.

Background: Colorectal cancer is a major cause of morbidity and mortality in the world. Approximately, one of three diagnosed colorectal cancers is a rectal cancer. Recent developments in the field of rectal surgery have promoted the use of surgical robots, which are of great need when surgeons face anatomical difficulties, such as a narrowed male pelvis, bulky tumor, or obese patients. This study aims to evaluate the clinical results of robotic rectal cancer surgery during the introduction period of a surgical robot system. Moreover, the period of the introduction of this technique coincided with the first year of the COVID-19 pandemic. Methods: Since December 2019, the Surgery Department of the University Hospital of Varna has become the newest and the most modern Robotic Surgery Center of Competence in Bulgaria, equipped with the most advanced da Vinci Xi surgical system. From January 2020 to October 2020 a total number of 43 patients have underwent surgical treatment, of which 21 had roboticassisted procedures and the rest - open procedures. Results: Patient characteristics were close between the studied groups. The mean patient age in robotic surgery was 65 years, as six of these patients were females, while in case of open surgery these values were to 70 and 6, respectively. Two thirds (66.7%) of the patients operated on with da Vinci Xi were with tumor stage 3 or 4 and approximately 10% had the tumor located in the lower part of the rectum. The median value of the operation time was 210 min, while the length of hospital stay was 7 days. These short-term parameters were not found to have a large difference in respect to the open surgery group. A significant difference is depicted for the number of lymph nodes resected and the blood loss, with both parameters demonstrating advantage for the robot-assisted surgery. The blood loss is more than twice less than the case of open surgery. Conclusions: The results confidently showed the successful introduction of the robot-assisted platform in the surgery department despite the limitations caused by the COVID-19 pandemic. This technique is expected to become the main choice of minimally invasive technique applied to all types of colorectal cancer surgery in the Robotic Surgery Center of Competence., (Celsius.)

Objective . In this study, a novel voxel-by-voxel mixing method is presented, according to which two filaments of different material are combined during the three dimensional (3D) printing process. Approach . In our approach, two types of filaments were used for the replication of soft-tissues, a polylactic acid (PLA) filament and a polypropylene (PP) filament. A custom-made software was used, while a series of breast patient CT scan images were directly associated to the 3D printing process. Each phantom´s layer was printed twice, once with the PLA filament and a second time with the PP filament. For each material, the filament extrusion rate was controlled voxel-by-voxel and was based on the Hounsfield units (HU) of the imported CT images. The phantom was scanned at clinical CT, breast tomosynthesis and micro CT facilities, as the major processing was performed on data from the CT. A side by side comparison between patient´s and phantom´s CT slices by means of profile and histogram comparison was accomplished. Further, in case of profile comparison, the Pearson´s coefficients were calculated. Main results . The visual assessment of the distribution of the glandular tissue in the CT slices of the printed breast anatomy showed high degree of radiological similarity to the corresponding patient´s glandular distribution. The profile plots´ comparison showed that the HU of the replicated and original patient soft tissues match adequately. In overall, the Pearson´s coefficients were above 0.91, suggesting a close match of the CT images of the phantom with those of the patient. The overall HU were close in terms of HU ranges. The HU mean, median and standard deviation of the original and the phantom CT slices were -149, -167, ±65 and -121, -130, ±91, respectively. Significance . The results suggest that the proposed methodology is appropriate for manufacturing of anthropomorphic soft tissue phantoms for x-ray imaging and dosimetry purposes, since it may offer an accurate replication of these tissues., (© 2022 Institute of Physics and Engineering in Medicine.)

Purpose: The aim of this study is the development of a methodology for manufacturing 3D printed anthropomorphic structures, which mimic the X-ray properties of the human bone tissue., Methods: A mixing approach of two different materials is proposed for the fabrication of a radiologically equivalent hip bone for an anthropomorphic abdominal phantom. The materials employed for the phantom were polylactic acid (PLA) and Stonefil, while a custom-made dual motor filament extrusion setup and a custom-made software associating medical images directly with the 3D printing process were employed., Results: Three phantoms representing the hip bone were 3D printed utilizing two filaments under three different printing scenarios. The phantoms are based on a patient's abdominal CT scan images. Histograms of CT scans of the printed hip bone phantoms were calculated and compared to the original patient's hip bone histogram, demonstrating that a constant mixing composition of 30% Stonefil and 70% PLA with 0.0375 extrusion rate per voxel (93.75% flow for fulfilling a single voxel) for the cancellous bone, and using 100% Stonefil with 0.04 extrusion rate per voxel (100% flow) for the cortical bone results in a realistic anatomy replication of the hip bone. Reproduced HU varied between 700 and 800, which are close to those of the hip bone., Conclusions: The study demonstrated that it is possible to mix two different filaments in real-time during the printing process to obtain phantoms with realistic and radiographically bone tissue equivalent attenuation. The results will be explored for manufacturing a CT-compatible abdominal phantom., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Associazione Italiana di Fisica Medica e Sanitaria. Published by Elsevier Ltd. All rights reserved.)

Purpose: To design, fabricate and characterize 3D printed, anatomically realistic, compressed breast phantoms for digital mammography (DM) and digital breast tomosynthesis (DBT) x-ray imaging., Materials: We realized 3D printed phantoms simulating healthy breasts, via fused deposition modeling (FDM), with a layer resolution of 0.1 mm and 100% infill density, using a dual extruder printer. The digital models were derived from a public dataset of segmented clinical breast computed tomography scans. Three physical phantoms were printed in polyethylene terephthalate (PET), acrylonitrile-butadiene-styrene (ABS), or in polylactic-acid (PLA) materials, using ABS as a substitute for adipose tissue, and PLA or PET filaments for replicating glandular and skin tissues. 3D printed phantoms were imaged at three clinical centers with DM and DBT scanners, using typical spectra. Anatomical noise of the manufactured phantoms was evaluated via the estimates of the β parameter both in DM images and in images acquired via a clinical computed tomography (CT) scanner., Results: DM and DBT phantom images showed an inner texture qualitatively similar to the images of a clinical DM or DBT exam, suitably reproducing the glandular structure of their computational phantoms. β parameters evaluated in DM images of the manufactured phantoms ranged between 2.84 and 3.79; a lower β was calculated from the CT scan., Conclusions: FDM 3D printed compressed breast phantoms have been fabricated using ABS, PLA and PET filaments. DM and DBT images with clinical x-ray spectra showed realistic textures. These phantoms appear promising for clinical applications in quality assurance, image quality and dosimetry assessments., (Copyright © 2022 Associazione Italiana di Fisica Medica e Sanitaria. Published by Elsevier Ltd. All rights reserved.)

Purpose: To evaluate the bias to the mean glandular dose (MGD) estimates introduced by the homogeneous breast models in digital breast tomosynthesis (DBT) and to have an insight into the glandular dose distributions in 2D (digital mammography, DM) and 3D (DBT and breast dedicated CT, BCT) x-ray breast imaging by employing breast models with realistic glandular tissue distribution and organ silhouette., Methods: A Monte Carlo software for DM, DBT and BCT simulations was adopted for the evaluation of glandular dose distribution in 60 computational anthropomorphic phantoms. These computational phantoms were derived from 3D breast images acquired via a clinical BCT scanner., Results: g·c·s·T conversion coefficients based on homogeneous breast model led to a MGD overestimate of 18% in DBT when compared to MGD estimated via anthropomorphic phantoms; this overestimate increased up to 21% for recently computed DgN DBT conversion coefficients. The standard deviation of the glandular dose distribution in BCT resulted 60% lower than in DM and 55% lower than in DBT. The glandular dose peak - evaluated as the average value over the 5% of the gland receiving the highest dose - is 2.8 times the MGD in DM, this factor reducing to 2.6 and 1.6 in DBT and BCT, respectively., Conclusions: Conventional conversion coefficients for MGD estimates based on homogeneous breast models overestimate MGD by 18%, when compared to MGD estimated via anthropomorphic phantoms. The ratio between the peak glandular dose and the MGD is 2.8 in DM. This ratio is 8% and 75% higher than in DBT and BCT, respectively., (Copyright © 2022 Associazione Italiana di Fisica Medica e Sanitaria. Published by Elsevier Ltd. All rights reserved.)

Objective . This work describes an approach for producing physical anthropomorphic breast phantoms from clinical patient data using three-dimensional (3D) fused-deposition modelling (FDM) printing. Approach . The source of the anthropomorphic model was a clinical Magnetic Resonance Imaging (MRI) patient image set, which was segmented slice by slice into adipose and glandular tissues, skin and tumour formations; thus obtaining a four component computational breast model. The segmented tissues were mapped to specific Hounsfield Units (HU) values, which were derived from clinical breast Computed Tomography (CT) data. The obtained computational model was used as a template for producing a physical anthropomorphic breast phantom using 3D printing. FDM technology with only one polylactic acid filament was used. The physical breast phantom was scanned at Siemens SOMATOM Definition CT. Quantitative and qualitative evaluation were carried out to assess the clinical realism of CT slices of the physical breast phantom. Main results . The comparison between selected slices from the computational breast phantom and CT slices of the physical breast phantom shows similar visual x-ray appearance of the four breast tissue structures: adipose, glandular, tumour and skin. The results from the task-based evaluation, which involved three radiologists, showed a high degree of realistic clinical radiological appearance of the modelled breast components. Measured HU values of the printed structures are within the range of HU values used in the computational phantom. Moreover, measured physical parameters of the breast phantom, such as weight and linear dimensions, agreed very well with the corresponding ones of the computational breast model. Significance . The presented approach, based on a single FDM material, was found suitable for manufacturing of a physical breast phantom, which mimics well the 3D spatial distribution of the different breast tissues and their x-ray absorption properties. As such, it could be successfully exploited in advanced x-ray breast imaging research applications., (Creative Commons Attribution license.)

Background and Objective: The development, control and optimisation of new x-ray breast imaging modalities could benefit from a quantitative assessment of the resulting image textures. The aim of this work was to develop a software tool for routine radiomics applications in breast imaging, which will also be available upon request., Methods: The tool (developed in MATLAB) allows image reading, selection of Regions of Interest (ROI), analysis and comparison. Requirements towards the tool also included convenient handling of common medical and simulated images, building and providing a library of commonly applied algorithms and a friendly graphical user interface. Initial set of features and analyses have been selected after a literature search. Being open, the tool can be extended, if necessary., Results: The tool allows semi-automatic extracting of ROIs, calculating and processing a total of 23 different metrics or features in 2D images and/or in 3D image volumes. Computations of the features were verified against computations with other software packages performed with test images. Two case studies illustrate the applicability of the tool - (i) features on a series of 2D 'left' and 'right' CC mammograms acquired on a Siemens Inspiration system were computed and compared, and (ii) evaluation of the suitability of newly proposed and developed breast phantoms for x-ray-based imaging based on reference values from clinical mammography images. Obtained results could steer the further development of the physical breast phantoms., Conclusions: A new image analysis toolbox was realized and can now be used in a multitude of radiomics applications, on both clinical and test images., (Copyright © 2021 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.)

Purpose: To present a dataset of computational digital breast phantoms derived from high-resolution three-dimensional (3D) clinical breast images for the use in virtual clinical trials in two-dimensional (2D) and 3D x-ray breast imaging., Acquisition and Validation Methods: Uncompressed computational breast phantoms for investigations in dedicated breast CT (BCT) were derived from 150 clinical 3D breast images acquired via a BCT scanner at UC Davis (California, USA). Each image voxel was classified in one out of the four main materials presented in the field of view: fibroglandular tissue, adipose tissue, skin tissue, and air. For the image classification, a semi-automatic software was developed. The semi-automatic classification was compared via manual glandular classification performed by two researchers. A total of 60 compressed computational phantoms for virtual clinical trials in digital mammography (DM) and digital breast tomosynthesis (DBT) were obtained from the corresponding uncompressed phantoms via a software algorithm simulating the compression and the elastic deformation of the breast, using the tissue's elastic coefficient. This process was evaluated in terms of glandular fraction modification introduced by the compression procedure. The generated cohort of 150 uncompressed computational breast phantoms presented a mean value of the glandular fraction by mass of 12.3%; the average diameter of the breast evaluated at the center of mass was 105 mm. Despite the slight differences between the two manual segmentations, the resulting glandular tissue segmentation did not consistently differ from that obtained via the semi-automatic classification. The difference between the glandular fraction by mass before and after the compression was 2.1% on average. The 60 compressed phantoms presented an average glandular fraction by mass of 12.1% and an average compressed thickness of 61 mm., Data Format and Access: The generated digital breast phantoms are stored in DICOM files. Image voxels can present one out of four values representing the different classified materials: 0 for the air, 1 for the adipose tissue, 2 for the glandular tissue, and 3 for the skin tissue. The generated computational phantoms datasets were stored in the Zenodo public repository for research purposes (http://doi.org/10.5281/zenodo.4529852, http://doi.org/10.5281/zenodo.4515360)., Potential Applications: The dataset developed within the INFN AGATA project will be used for developing a platform for virtual clinical trials in x-ray breast imaging and dosimetry. In addition, they will represent a valid support for introducing new breast models for dose estimates in 2D and 3D x-ray breast imaging and as models for manufacturing anthropomorphic physical phantoms., (© 2021 American Association of Physicists in Medicine.)

Anthropomorphic breast phantoms are both, computational and physical, anatomically and radiologically realistic models of the human female breast, and are considered an excellent tool for development, comparing, characterizing and optimizing of novel and existing breast screening and diagnostic modalities. Their role in the objective assessment of diagnostic task performance of breast imaging systems without conducting high cost and time-consuming clinical trials, as well as in developing and optimizing clinical protocols and image reconstruction algorithms is tangible increasing. The aim of this paper is to present a historical journey from the advent of the breast anthropomorphic models used with x-ray modalities, their further development and realistic improvement, to current achievements. Anthropomorphic breast models are both computational and physical. Computational phantoms are mainly based on mathematical formulations and patient medical images. The mathematical breast models consist of mathematical description of the breast structures, while the patient-based are created from segmented clinical datasets acquired by dedicated breast Computed Tomography. The later approach guarantees a very high degree of realism. Molding techniques, 3D printing and low cost paper-based approaches are the main methods for creation of physical breast anthropomorphic models. Among them, 3D printing technologies provide an excellent opportunity to create realistic models of the breast by using a number of printing materials with x-ray characteristics similar to these of breast tissues. The anatomical and radiological realism of the anthropomorphic breast phantoms together with the possibility for unlimited exposure during important diagnostic tasks is transforming them into a key instrument of every Radiology Department., (Copyright © 2020 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.)

Virtual clinical trials (VCT) are in-silico reproductions of medical examinations, which adopt digital models of patients and simulated devices. They are intended to produce clinically equivalent outcome data avoiding long execution times, ethical issues related to radiation induced risks and huge costs related to real clinical trials with a patient population. In this work, we present a platform for VCT in 2D and 3D X-ray breast imaging. The VCT platform uses Monte Carlo simulations based on the Geant4 toolkit and patient breast models derived from a cohort of high resolution dedicated breast CT (BCT) volume data sets. Projection images of the breast and three-dimensional glandular dose maps are generated for a given breast model, by simulating both 2D full-field digital mammography (DM) and 3D BCT examinations. Uncompressed voxelized breast models were derived from segmented patient images. Compressed versions of the digital breast phantoms for DM were generated using a previously published digital compression algorithm. The Monte Carlo simulation framework has the capability of generating and tracking ~10 5  photons/s using a server equipped with 16-cores and 3.0 GHz clock speed. The VCT platform will provide a framework for scanner design optimization, comparison between different scanner designs and between different modalities or protocols on computational breast models, without the need for scanning actual patients as in conventional clinical trials., (Copyright © 2020 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.)

Purpose: We present the development and the current state of the MaXIMA Breast Lesions Models Database, which is intended to provide researchers with both segmented and mathematical computer-based breast lesion models with realistic shape., Methods: The database contains various 3D images of breast lesions of irregular shapes, collected from routine patient examinations or dedicated scientific experiments. It also contains images of simulated tumour models. In order to extract the 3D shapes of the breast cancers from patient images, an in-house segmentation algorithm was developed for the analysis of 50 tomosynthesis sets from patients diagnosed with malignant and benign lesions. In addition, computed tomography (CT) scans of three breast mastectomy cases were added, as well as five whole-body CT scans. The segmentation algorithm includes a series of image processing operations and region-growing techniques with minimal interaction from the user, with the purpose of finding and segmenting the areas of the lesion. Mathematically modelled computational breast lesions, also stored in the database, are based on the 3D random walk approach., Results: The MaXIMA Imaging Database currently contains 50 breast cancer models obtained by segmentation of 3D patient breast tomosynthesis images; 8 models obtained by segmentation of whole body and breast cadavers CT images; and 80 models based on a mathematical algorithm. Each record in the database is supported with relevant information. Two applications of the database are highlighted: inserting the lesions into computationally generated breast phantoms and an approach in generating mammography images with variously shaped breast lesion models from the database for evaluation purposes. Both cases demonstrate the implementation of multiple scenarios and of an unlimited number of cases, which can be used for further software modelling and investigation of breast imaging techniques. The created database interface is web-based, user friendly and is intended to be made freely accessible through internet after the completion of the MaXIMA project., Conclusions: The developed database will serve as an imaging data source for researchers, working on breast diagnostic imaging and on improving early breast cancer detection techniques, using existing or newly developed imaging modalities., (Copyright © 2019. Published by Elsevier Ltd.)

This paper presents a method for creation of computational models of breast lesions with irregular shapes from patient Digital Breast Tomosynthesis (DBT) images or breast cadavers and whole-body Computed Tomography (CT) images. The approach includes six basic steps: (a) normalization of the intensity of the tomographic images; (b) image noise reduction; (c) binarization of the lesion area, (d) application of morphological operations to further decrease the level of artefacts; (e) application of a region growing technique to segment the lesion; and (f) creation of a final 3D lesion model. The algorithm is semi-automatic as the initial selection of the region of the lesion and the seeds for the region growing are done interactively. A software tool, performing all of the required steps, was developed in MATLAB. The method was tested and evaluated by analysing anonymized sets of DBT patient images diagnosed with lesions. Experienced radiologists evaluated the segmentation of the tumours in the slices and the obtained 3D lesion shapes. They concluded for a quite satisfactory delineation of the lesions. In addition, for three DBT cases, a delineation of the tumours was performed independently by the radiologists. In all cases the abnormality volumes segmented by the proposed algorithm were smaller than those outlined by the experts. The calculated Dice similarity coefficients for algorithm-radiologist and radiologist-radiologist showed similar values. Another selected tumour case was introduced into a computational breast model to recursively assess the algorithm. The relative volume difference between the ground-truth tumour volume and the one obtained by applying the algorithm on the synthetic volume from the virtual DBT study is 5% which demonstrates the satisfactory performance of the proposed segmentation algorithm. The software tool we developed was used to create models of different breast abnormalities, which were then stored in a database for use by researchers working in this field., (Copyright © 2018 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.)

Purpose: To provide mean glandular dose (MGD) estimates via Monte Carlo (MC) simulations as a function of the breast models and scan parameters in mammography, digital breast tomosynthesis (DBT) and dedicated breast CT (BCT)., Methods: The MC code was based on GEANT4 toolkit. The simulated compressed breast was either a cylinder with a semi-circular section or ad hoc shaped for oblique view (MLO). In DBT we studied the influence of breast models and exam parameters on the T-factors (i.e. the conversion factor for the calculation of the MGD in DBT from that for a 0-degree projection), and in BCT we investigated the influence on the MGD estimates of the ion chamber volume used for the air kerma measurements., Results: In mammography, a model representative of a breast undergoing an MLO view exam did not produce substantial differences (0.4%) in MGD estimates, when compared to a conventional cranio-caudal (CC) view breast model. The beam half value layer did not present a significant influence on T-factors in DBT (<0.8%), while the skin model presented significant influence on MGD estimates (up to 3.3% at 30 degrees scan angle), increasing for larger scan angles. We derived a correction factor for taking into account the different ion chamber volume used in MGD estimates in BCT., Conclusions: A series of MC code modules for MGD estimates in 2D and 3D breast imaging have been developed in order to take into account the most recent advances in breast models., (Copyright © 2018 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.)

Recent studies on murine models have demonstrated the potential of dark field (DF) x-ray imaging for lung diseases. The alveolar microstructure causes small angle scattering, which is visualised in DF images. Whether DF imaging works for human lungs is not a priori guaranteed as human alveoli are larger and system settings for murine imaging will probably have to be adapted. This work examines the potential of translating DF imaging to human lungs. The DF contrast due to murine and human lung models was studied using numerical wave propagation simulations, where the lungs were modelled as a volume filled with spheres. Three sphere diameters were used: 39, 60 and 80 μm for the murine model and 200, 300 and 400 μm spheres for the human model. System settings applied for murine lung response modelling were taken from a prototype grating interferometry scanner used in murine lung experiments. The settings simulated for human lung imaging simulations combine the requirements for grating interferometry and conventional chest RX in terms of x-ray energy and pixel size. The DF signal in the simulated murine model was consistent with results from experimental DF data. The simulated linear diffusion coefficient for medium alveoli diameters was found to be (1.31±0.01)⋅10-11 mm-1, 120 times larger than those of human lung tissue ((1.09±0.01)⋅10-13 mm-1). However, as the human thorax is typically a factor 15 times larger than that of murine animals, the overall DF effect in human lungs remains substantial. At the largest lung thickness and for the DF setup simulated, human lungs have an estimated DF response of around 0.31 and murine lungs of 0.23. Dark field imaging can therefore be considered a promising modality for use in human lung imaging., Competing Interests: The authors have declared that no competing interests exist.

Breast physical phantoms are a basic tool for the assessment and verification of performance standards in daily clinical practice of x-ray breast imaging modalities. They are also invaluable in testing and evaluation of new x-ray breast modalities to be potentially established, e.g. breast computed tomography, dual-energy breast CT and phase-contrast mammography and tomography. Nowadays, there is a lack or there are only a limited number of breast physical phantoms available for this purpose. The aim of this study is to explore a range of 3D printing materials such as resins, PLA, ABS, Nylon etc, to determine their attenuation and refractive properties, and to finally compare them to the properties of the breast tissues: adipose, glandular and skin. To achieve this goal, step-wedge phantoms were computationally modeled and then manufactured using stereolithographic and fused-deposition modeling technologies. X-ray images of the phantoms were acquired, using monochromatic beam at ID17, ESRF, Grenoble for three energies-30 keV, 45 keV and 60 keV. Experimental data were further processed to obtain the linear attenuation coefficients of these materials. Comparison with theoretical data for the linear attenuation coefficients and the refractive indexes for breast tissues was performed. From the studied materials, most of the resins, Nylon, Hybrid, PET-G show absorption properties close to the glandular tissue, while ABS shows absorption characteristics close to these of the adipose tissue. For phase-contrast imaging, it turns out that the ABS combined with resin-based materials to represent the adipose and glandular tissues, respectively may be a good combination for manufacturing of a phantom suitable for these studies. These results can be used for the design and the construction of a new physical anthropomorphic phantom of the breast with improved anatomical and radiological characteristics dedicated for advanced mammography imaging techniques implemented at higher photon energies.

Purpose: To compare, via Monte Carlo simulations, homogeneous and non-homogenous breast models adopted for mean glandular dose (MGD) estimates in mammography vs. patient specific digital breast phantoms., Methods: We developed a GEANT4 Monte Carlo code simulating four homogenous cylindrical breast models featured as follows: (1) semi-cylindrical section enveloped in a 5-mm adipose layer; (2) semi-elliptical section with a 4-mm thick skin; (3) semi-cylindrical section with a 1.45-mm skin layer; (4) semi-cylindrical section in a 1.45-mm skin layer and 2-mm subcutaneous adipose layer. Twenty patient specific digital breast phantoms produced from a dedicated CT scanner were assumed as reference in the comparison. We simulated two spectra produced from two anode/filter combinations. An additional digital breast phantom was produced via BreastSimulator software., Results: With reference to the results for patient-specific breast phantoms and for W/Al spectra, models #1 and #3 showed higher MGD values by about 1% (ranges [-33%; +28%] and [-31%; +30%], respectively), while for model #4 it was 2% lower (range [-34%; +26%]) and for model #2 -11% (range [-39%; +14%]), on average. On the other hand, for W/Rh spectra, models #1 and #4 showed lower MGD values by 2% and 1%, while for model #2 and #3 it was 14% and 8% lower, respectively (ranges [-43%; +13%] and [-41%; +21%]). The simulation with the digital breast phantom produced with BreastSimulator showed a MGD overestimation of +33%., Conclusions: The homogeneous breast models led to maximum MGD underestimation and overestimation of 43% and 28%, respectively, when compared to patient specific breast phantoms derived from clinical CT scans., (Copyright © 2018 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.)

Purpose: In cone-beam computed tomography dedicated to the breast (BCT), the mean glandular dose (MGD) is the dose metric of reference, evaluated from the measured air kerma by means of normalized glandular dose coefficients (DgN CT ). This work aimed at computing, for a simple breast model, a set of DgN CT values for monoenergetic and polyenergetic X-ray beams, and at validating the results vs. those for patient specific digital phantoms from BCT scans., Methods: We developed a Monte Carlo code for calculation of monoenergetic DgN CT coefficients (energy range 4.25-82.25 keV). The pendant breast was modelled as a cylinder of a homogeneous mixture of adipose and glandular tissue with glandular fractions by mass of 0.1%, 14.3%, 25%, 50% or 100%, enveloped by a 1.45 mm-thick skin layer. The breast diameter ranged between 8 cm and 18 cm. Then, polyenergetic DgN CT coefficients were analytically derived for 49-kVp W-anode spectra (half value layer 1.25-1.50 mm Al), as in a commercial BCT scanner. We compared the homogeneous models to 20 digital phantoms produced from classified 3D breast images., Results: Polyenergetic DgN CT resulted 13% lower than most recent published data. The comparison vs. patient specific breast phantoms showed that the homogeneous cylindrical model leads to a DgN CT percentage difference between -15% and +27%, with an average overestimation of 8%., Conclusions: A dataset of monoenergetic and polyenergetic DgN CT coefficients for BCT was provided. Patient specific breast models showed a different volume distribution of glandular dose and determined a DgN CT 8% lower, on average, than homogeneous breast model., (Copyright © 2018 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.)

Introduction: In X-ray imaging, test objects reproducing breast anatomy characteristics are realized to optimize issues such as image processing or reconstruction, lesion detection performance, image quality and radiation induced detriment. Recently, a physical phantom with a structured background has been introduced for both 2D mammography and breast tomosynthesis. A software version of this phantom and a few related versions are now available and a comparison between these 3D software phantoms and the physical phantom will be presented., Methods: The software breast phantom simulates a semi-cylindrical container filled with spherical beads of different diameters. Four computational breast phantoms were generated with a dedicated software application and for two of these, physical phantoms are also available and they are used for the side by side comparison. Planar projections in mammography and tomosynthesis were simulated under identical incident air kerma conditions. Tomosynthesis slices were reconstructed with an in-house developed reconstruction software. In addition to a visual comparison, parameters like fractal dimension, power law exponent β and second order statistics (skewness, kurtosis) of planar projections and tomosynthesis reconstructed images were compared., Results: Visually, an excellent agreement between simulated and real planar and tomosynthesis images is observed. The comparison shows also an overall very good agreement between parameters evaluated from simulated and experimental images., Conclusion: The computational breast phantoms showed a close match with their physical versions. The detailed mathematical analysis of the images confirms the agreement between real and simulated 2D mammography and tomosynthesis images. The software phantom is ready for optimization purpose and extrapolation of the phantom to other breast imaging techniques., (Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.)

Purpose: To characterize the dependence of normalized glandular dose (DgN) on various breast model and image acquisition parameters during spot compression mammography and other partial breast irradiation conditions, and evaluate alternative previously proposed dose-related metrics for this breast imaging modality., Methods: Using Monte Carlo simulations with both simple homogeneous breast models and patient-specific breasts, three different dose-related metrics for spot compression mammography were compared: the standard DgN, the normalized glandular dose to only the directly irradiated portion of the breast (DgNv), and the DgN obtained by the product of the DgN for full field irradiation and the ratio of the mid-height area of the irradiated breast to the entire breast area (DgN M ). How these metrics vary with field-of-view size, spot area thickness, x-ray energy, spot area and position, breast shape and size, and system geometry was characterized for the simple breast model and a comparison of the simple model results to those with patient-specific breasts was also performed., Results: The DgN in spot compression mammography can vary considerably with breast area. However, the difference in breast thickness between the spot compressed area and the uncompressed area does not introduce a variation in DgN. As long as the spot compressed area is completely within the breast area and only the compressed breast portion is directly irradiated, its position and size does not introduce a variation in DgN for the homogeneous breast model. As expected, DgN is lower than DgNv for all partial breast irradiation areas, especially when considering spot compression areas within the clinically used range. DgN M underestimates DgN by 6.7% for a W/Rh spectrum at 28 kVp and for a 9 × 9 cm 2 compression paddle., Conclusion: As part of the development of a new breast dosimetry model, a task undertaken by the American Association of Physicists in Medicine and the European Federation of Organizations of Medical Physics, these results provide insight on how DgN and two alternative dose metrics behave with various image acquisition and model parameters., (© 2017 American Association of Physicists in Medicine.)

Purpose: Breast augmentation is one of the most popular cosmetic surgeries worldwide. The aim of this study is to investigate the effect of breast implant insertion on the detectability and visibility of lesions on mammography and breast tomosynthesis (BT) images., Materials and Methods: Three software phantoms, composed of a homogeneous background with embedded silicone gel structures, and two types of breast abnormalities, microcalcifications (µCs) and masses, were generated. Two X-ray breast imaging modalities were simulated: mammography and BT with six incident monochromatic X-ray beams with energies in the interval between 20 and 30 keV. Projection images were generated using an in-house developed Monte Carlo simulator. The detectability of mammographic findings adjacent to the implant material and the influence of the incident beam energy and implant thickness on the feature detection were studied., Results: It was found that implants thicker than 26 mm for the case of mammography and 14 mm for the case of BT obscured the visibility of underlying structures. Although BT demonstrated a lack of contrast, this modality was able to visualize µCs under considerable depths of implant. Increasing the incident beam energy led to better visualization of small µCs, while in the case of breast masses, their detectability was limited., Conclusions: Silicone gel implants introduce a limitation in the image quality of mammograms resulting in low detectability of features. In addition, silicone gel implants obscure partially or totally parts of the image, depending on the size and the thickness of the implant as well the energy of the X-rays used., (Copyright © 2016 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.)

Objective: The aim of this study is to investigate the validity of using the Multiple Projection Algorithm (MPA) for Breast Tomosynthesis (BT) using real projection images acquired with phantoms at a clinical setting., Methods: The CIRS-BR3D phantom with ranging thicknesses between 3 cm and 6 cm was used for all image quality evaluations. Five sets of measurements were acquired, each comprised of a 2D mammographic image followed by a set of 25 projections within an arc length of 50°. A reconstruction algorithm based on the MPA was adapted for partial isocentric rotation using a stationary detector. For reference purposes, a Back Projection (BP) algorithm was also developed for this geometry. The performance of the algorithms was evaluated, in combination with pre-filtering of the projections, in comparative studies that involved also a comparison between tomosynthesis slices and 2D mammograms., Results: Evaluation of tomosynthesis slices reconstructed with BP and MPA showed close performance for the two algorithms with no considerable differences in feature detection, size and appearance of the background tissue with the MPA running faster the overall process. Pre-filtering of the projections, led to better BT images compared to non-filtering. Increased thickness resulted in limited detection of the features of interest, especially the smaller sized ones. In these cases, the filtered BT slices allowed improved visualization due to removed superimposed tissue compared to the 2D images. The different breast-like slab arrangements in phantoms of the same thickness demonstrated a slight influence on the quality of reconstructed features., Conclusions: The MPA which had been applied previously to reconstruct tomograms from projections acquired at synchrotron facilities, is a time efficient algorithm, and is fully compliant with and can be successfully used in BT clinical systems. Compared to 2D mammography, BT shows advantage in visualizing features of small size and for increased phantom thickness or features within a dense background with superimposed structures.