Non-uniform thickness breast imaging phantom for 2D / 3D / spectral imaging

Abstract

A breast phantom (200, 300) having a non-uniform thickness is provided to simulate a clinically actual change in the thickness of a compressed breast when in contact with a compression paddle (28) during a mammography imaging procedure. Due to the non-uniform thickness, the breast phantom (200, 300) enables the image quality of the mammography imaging device (10) in terms of the image correction process and / or algorithm employed by the mammography imaging device (10) to be tested in order to address non-uniformity in the thickness of the imaged breast. The breast phantom (200, 300) may be made from one or more portions (302, 304, 306, 308), wherein one or more of the portions (302, 304, 306, 308) have a non-uniform thickness.

Description

Technical Field

[0001] The present disclosure relates generally to phantoms for medical imaging systems, including mammography systems and apparatus, and more particularly to breast phantom structures for mammography systems. Background Art

[0002] Embodiments of the present invention relate generally to X-ray medical imaging, and more particularly to apparatus, systems and methods for performing various imaging procedures, such as mammographic imaging procedures, including but not limited to spectral mammography (SM), such as 2D / 3D dual energy contrast enhanced (CE) mammography, full field digital mammography (FFDM), or digital breast fusion tomography (DBT) mammography.

[0003] Spectral mammography (SM) is an X-ray imaging modality used to scan the breast for screening, diagnosis and / or interventional examinations. The effectiveness of spectral mammography is affected by many factors, one of which is the two-dimensional (2D) rendering of the images obtained using SM.

[0004] Alternative systems to SM are also known for breast imaging. Some examples include full-field digital mammography that captures images directly onto a flat-panel detector, computed X-ray radiography involving the use of a cassette containing imaging plates, or digital breast fusion tomography (DBT). A digital breast fusion tomography (DBT) or mammo-tomo system is a specialized mammography system that acquires several (e.g., dozens) of angularly offset projection X-ray images and reconstructs a three-dimensional (3D) image data set using the resulting X-ray image data.

[0005] The 3D image dataset is used to form various volumetric representations of the imaged breast, including the entire 3D volume of the breast, and various 3D segments of the 3D volume, such as slices or slabs of specified thickness constituting the 3D volume oriented to provide desired views of one or more regions of interest (ROIs) detected within the 3D image dataset.

[0006] Additionally, when a 3D image dataset of the breast has been generated, after use in a suitable diagnostic procedure, these 3D image datasets can be used to guide a biopsy device used with a DBT system into the breast to obtain a biopsy of a region of interest (ROI) identified within the 3D image dataset. In a DBT system, the biopsy device is disposed directly on the DBT system so that the 3D image dataset can be used to guide the biopsy device to the ROI to perform the biopsy.

[0007] With respect to the use of these DBT mammography systems, the system setup to obtain images requires that various devices be attached to the system in order to provide the system with the correct positioning (i.e., compression) of the breast to obtain the desired image quality. In a mammography system, the devices attached to the system to perform imaging and / or biopsy procedures include compression paddles, a bucky or detector holder, and a breast support surface, and a biopsy holder that is used to position the biopsy device on the mammography system in a position where the biopsy device can perform the desired biopsy procedure under the guidance of the mammography system.

[0008] For diagnostic mammographic imaging devices such as those disclosed in U.S. Patent Application Publication No. US20200060632, entitled “Apparatus And Method For Mammography Breast Compression,” it is necessary to evaluate the ability of the mammographic imaging device to provide images of the breast of sufficient quality for diagnostic purposes, the entire contents of which are expressly incorporated herein by reference for all purposes. To perform these evaluations, a breast phantom is used. The breast phantom is formed of materials that simulate the physical structure of the breast, such as the compressibility of the breast and different types of tissue that may be present in the breast and to be detected by a mammographic imaging device or system. Because the breast phantom has a known structure in which materials in known locations simulate the type of tissue to be detected by the mammographic imaging device, the breast phantom, when positioned on the mammographic imaging device, can be used to test the ability of the mammographic imaging device to provide accurate and detailed images of the breast phantom structure compared to the known structure of the breast phantom.

[0009] Although the structure of the prior art breast phantom is suitable for generally representing the overall structure and type of tissue present in the breast, these prior art breast phantoms suffer from many deficiencies when used to evaluate mammographic imaging equipment. For example, because the phantom is formed to approximate the structure of the breast without any connection to adjacent anatomical structures (such as the chest wall), the compression of the breast phantom is close to uniform across the phantom. However, due to the connection of the actual breast to the chest wall, for mammographic imaging procedures, the chest wall generally produces non-uniformity in the compressed thickness of the breast between the compression paddle and the compression or support surface on the detector. This non-uniform thickness can exist in one or both of the anterior / posterior direction and the lateral direction. Because non-uniform compressed thickness often occurs in mammographic imaging procedures, the federal regulations cover the quality standard requirement for compression paddles used in mammographic imaging procedures in 21 CFR § 900.12 (b) (8) (ii) (C) that "the compression paddle should be flat and parallel to the breast support table, and should not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied." Therefore, during evaluation or testing of mammographic imaging equipment, it is necessary to accommodate imaging of breasts having a compression thickness that causes the compression paddles to deflect up to 1.0 cm from parallel to the breast support / detector surface. Therefore, prior art breast phantoms that do not provide for a non-uniform compression thickness that causes the compression paddles to deflect up to 1.0 cm from parallel are unable to effectively evaluate mammographic imaging equipment over the full range of operating conditions for the imaging equipment.

[0010] Furthermore, in order to effectively evaluate the performance of a mammographic imaging device in providing accurate images of a breast phantom, the reproducibility of the images of the phantom obtained by the mammographic imaging device must be demonstrated. However, the compressibility of prior art breast phantoms does not allow for repeatable compression of the breast, such that in each test setup the phantom is compressed in at least a slightly different manner and the resulting images of the phantom are not reproducible between different setups.

[0011]

[0006] Therefore, in light of the above-mentioned shortcomings of prior art breast phantoms used in the evaluation of mammographic imaging devices or systems, it would be desirable to develop a breast phantom that more realistically approximates uneven compression of the breast in an easily reproducible manner. Summary of the invention

[0012] According to one aspect of an exemplary embodiment of the present disclosure, a breast phantom is provided having a non-uniform thickness to simulate clinically realistic variations in thickness of a compressed breast when in contact with a compression paddle during a mammographic imaging procedure. Due to the non-uniform thickness, the breast phantom enables testing of the image quality of a mammographic imaging device in terms of image correction processes and / or algorithms employed by the mammographic imaging device to account for the non-uniformity in thickness of the imaged breast.

[0013] In another aspect of an exemplary embodiment of the present disclosure, a breast phantom can be made of one or more sections, wherein one or more of the sections have a non-uniform thickness. In this way, when combined with multiple sections of different materials, backgrounds, and / or non-uniform thicknesses, a breast phantom can be formed to have various combinations of backgrounds, total thicknesses, and various non-uniform thickness orientations, among other characteristics.

[0014] According to another aspect of an exemplary embodiment of the present disclosure, a mammographic phantom includes a non-uniform thickness body formed of a breast equivalent material, the body including an inclined upper surface and a plurality of test plugs disposed within the body.

[0015] According to yet another aspect of an exemplary embodiment of the present disclosure, a top portion for a breast phantom includes a non-uniform thickness body having an inclined upper surface.

[0016] According to another aspect of an exemplary embodiment of the present disclosure, a method for evaluating the performance of a mammographic imaging device including an image correction algorithm includes the following steps: providing a mammographic imaging device having: a gantry including: a radiation source; a detector alignable with the radiation source and defining a compression surface; and a compression paddle movably disposed on the gantry and between the radiation source and the detector; and a controller operably connected to the gantry to control the operation of the compression paddle, the radiation source, and the detector to generate image data, the controller including a central processing unit and interconnected electronic storage units for processing image data from the detector to form an image using the image correction algorithm; providing a mammographic phantom having a non-uniform thickness body and a plurality of test plugs disposed within the body, the non-uniform thickness body being formed of a breast equivalent material, the body including an inclined upper surface; and engaging the phantom between the compression paddle and the compression surface, and obtaining image data of the phantom for evaluating the performance of the mammographic imaging device and the image correction algorithm.

[0017] These and other exemplary aspects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The drawings illustrate the best mode presently contemplated of practicing the invention.

[0019] In the attached picture:

[0020] Figure 1 is a perspective view of an X-ray imaging device in the form of a mammographic imaging device for imaging breast tissue of a patient in accordance with an embodiment of the present disclosure.

[0021] Figure 2 According to the present disclosure Figure 1 A diagram of a mammographic imaging apparatus showing a radiation source of the system in a scanning position.

[0022] Figure 3 Is Figure 1 An image correction algorithm employed by a mammographic imaging device provides enhanced illustration of an image of a non-uniform thickness breast having varying thickness.

[0023] Figure 4 is an isometric view of a first embodiment of a breast phantom according to the present disclosure.

[0024] Figure 5 According to the present disclosure Figure 4 Cross-sectional view of a breast phantom in a first imaging configuration.

[0025] Figure 6 is an isometric view of a second embodiment of a breast phantom according to the present disclosure.

[0026] Figure 7 According to the present disclosure Figure 6 Cross-sectional view of a breast phantom.

[0027] FIG. 8A to FIG. 8C According to the present disclosure Figure 6 Cross-sectional views of different top sections used in the phantom.

[0028] Fig. 9 According to the present disclosure, Figure 6 Diagram of different configurations of breast phantoms with varying numbers of sections and accompanying thicknesses. DETAILED DESCRIPTION

[0029] One or more specific embodiments will be described below. In order to provide a concise description of these embodiments, all features of an actual implementation may not be described in the specification. It should be understood that, as in any engineering or design project, in the development of any such actual implementation, numerous implementation-specific decisions must be made to achieve the developer's specific goals, such as complying with system-related and business-related constraints that may differ between implementations. In addition, it should be understood that such development efforts may be complex and time-consuming, but are still routine tasks of design, fabrication, and manufacturing for ordinary technicians who benefit from this disclosure.

[0030] When introducing elements of various embodiments of the present invention, the articles "a," "an," "the," and "said" are intended to mean that there are one or more of such elements. The terms "comprising," "including," and "having" are intended to be inclusive, and mean that there may be additional elements in addition to the listed elements. Furthermore, any numerical examples in the following discussion are intended to be non-limiting, and thus the additional numerical values, ranges, and percentages are within the scope of the disclosed embodiments.

[0031] As used herein, "electrically coupled," "electrically connected," and "electrically communicating" means that the referenced elements are directly or indirectly connected such that current can flow from one to the other. The connection may include a direct conductive connection (i.e., without intervening capacitors, inductors, or active elements), an inductive connection, a capacitive connection, and / or any other suitable electrical connection. There may be intervening components.

[0032] Furthermore, although the embodiments disclosed herein are described with respect to mammographic apparatus for 2-dimensional imaging of breast tissue, it should be understood that embodiments of the present invention may be applicable to other types of imaging devices for both 2-dimensional and 3-dimensional imaging, including, for example, fluoroscopy, full-field digital mammography, digital breast fusion tomography (DBT), and spectral mammography (mono- or multi-energy), as well as other types of imaging devices for imaging procedures of tissues other than breast tissue. Still further, embodiments of the present invention may be used to analyze tissues generally, and are not limited to analyzing human tissues.

[0033] Reference now Figure 1 and Figure 2 , showing the main components of an exemplary X-ray imaging device 10 formed as a mammographic imaging device 12 for imaging breast tissue according to an embodiment of the present invention. The imaging device 10 includes a radiation source / X-ray source 16, a radiation detector 18, and a collimator 20, and the imaging device is disclosed in U.S. Patent Application Publication No. US20200060632 entitled Apparatus And Method For Mammography Breast Compression, the entire contents of which are expressly incorporated herein by reference for all purposes. The radiation source 16 is movable between multiple imaging positions relative to the detector 18 and is operable to emit radiation rays 22 ( Figure 2 ), which radiation rays are received by the radiation detector 18 to provide an image of an object such as a breast 52. In an embodiment, the mammographic imaging device 12 may include a patient shield 24 mounted to the radiation source 16 via a mask rail 26 to prevent the patient's head from blocking the radiation rays and to protect the patient from the radiation rays 22.

[0034] Still further reference Figure 1 and Figure 2 , the mammographic imaging device 12 also includes a compression paddle or plate 28 and a support structure 30 to which one or more of the radiation source 16, the radiation detector 18, and / or the compression plate 28 are mounted. In an embodiment, the mammographic imaging device 12 may also include a controller 32. The controller 32 may be a workstation having at least one processor / central processing unit / computer and a memory device / database storing information and / or instructions used by the controller 32 for the operation of the mammographic imaging device 12, such as Figure 1 As shown, or in other embodiments, the controller 32 may be embedded / integrated into one or more of the various components of the mammographic imaging device 12 disclosed above. In an embodiment, the controller 32 may be in electrical communication with the radiation source 16, the radiation detector 18, and / or the compression plate 28 via a cable 34. As will be appreciated, in an embodiment, the connection 34 may be a wireless connection. In an embodiment, the controller 32 may include a radiation shield 36 that protects an operator of the mammographic imaging device 12 from the radiation rays 22 emitted by the radiation source 16. The controller 32 may also include a display 38, a keyboard 40, a mouse 42, and / or other appropriate user input devices that facilitate control of the mammographic imaging device 12 via a user interface 44.

[0035] like Figure 1 and Figure 2 As further shown, the radiation source 16, together with the radiation detector 18, forms part of an X-ray system that provides X-ray images for the purpose of imaging a body part of a patient, such as a breast 52. As described above, the radiation source 16 emits radiation rays 22 such that the radiation rays 22 travel from the radiation source 16 to the radiation detector 18. Although the radiation rays 22 are discussed herein as X-rays, it should be understood that the radiation source 16 may emit other types of electromagnetic rays that can be used to image a patient. The radiation source 16 may be mounted to the support structure 30 so that the radiation source can rotate relative to the radiation detector 18 about an axis 46, but movement of the radiation source 16 in a path other than rotation about a fixed axis, such as during digital breast fusion tomography (DBT), is also contemplated. In an embodiment, the radiation detector 18 may be configured to rotate or translate within its housing, such as in the directions indicated by arrows 53 and 55.

[0036] exist Figure 2In the illustrated exemplary embodiment of , the radiation source 16 and the detector 18 are mounted to a gantry 90 that is secured to the support structure 30. The support structure 30 houses a translation mechanism 92 that is operably connected to the gantry 90. The translation mechanism 92 is operable to vertically move the gantry 90 relative to the support structure 30 so as to position the gantry 90 at an appropriate height to accommodate the size of the patient on which the mammographic imaging device 12 is utilized. The translation mechanism 92 is also operable to rotate the gantry 90 about the horizontal axis 46 relative to the support structure 30 so as to rotationally position the gantry 90 relative to the patient as desired.

[0037] The gantry 90 includes a generally C-shaped body 94 with the radiation source 16 at one end and the detector 18 at the opposite end. In this configuration, the radiation source 16 is disposed in alignment with the detector 18 regardless of the vertical and / or rotational orientation of the gantry 90, such as to position the radiation source 16 and the detector 18 relative to the patient's breast 52 to obtain X-ray images in various orientations, such as for craniocaudal (CC) or mediolateral oblique (MLO) views, etc. In this position, the detector 18 is capable of receiving X-rays 22 emitted from the radiation source 16 that pass through the portion of the patient, i.e., the patient's breast 52, located between the radiation source 16 and the detector 18 to generate image data for transmission to the control system 32 of the mammographic imaging device 12 to create / reconstruct a 3D image data set for viewing by a physician (such as by using DBT), among other known methods.

[0038] Additionally, in another embodiment, the radiation source 16 may be attached to the gantry 90 to rotate and / or move independently of the gantry 90 and the detector 18 to enable the radiation source 16 to capture X-ray images of the patient's breast at various angles (e.g., between + / - 60°) relative to the detector 18. The images obtained by the radiation source 16 between these angles may be used to create stereoscopic images during a biopsy procedure using the mammographic imaging device 12 or for DBT when the mammographic imaging device 12 is operated in the imaging mode.

[0039] As described above, radiation detector 18 receives radiation rays 22 emitted by radiation source 16. In an embodiment, data regarding radiation rays 22 received by radiation detector 18 may be electronically transmitted from radiation detector 18 to controller 32 via cable / electronic connection 34, so that controller 32 generates one or more images that may be displayed on display 38 and stored in a memory device.

[0040] The compression plate 28 is operable to move toward and away from the radiation detector 18, as indicated by the arrow / compression axis 48, in response to instructions from the controller 32 or in response to instructions from a controller such as a remote control 84 or a switch controller 80 connected by a cable 82 on or near the mammographic imaging device 12, so that the compression plate 28 flattens and holds a body part (e.g., a breast 52) ​​in place against the surface 50 of the radiation detector 18. In this regard, the radiation detector 18 and its housing or surface 50 are referred to herein as a "compression surface or support plate" that cooperates with the compression plate 28 to compress and clamp the patient's breast 52 therebetween.

[0041] In many cases, the compression of the breast 52 between the compression plate 28 and the compression surface 50 results in uneven compression of the breast 52, wherein the thickness of the breast 52 at the compressed location is not equal over the area between the compression plate 28 and the compression surface 50. This uneven compression is due to a variety of factors, including the attachment of the breast 52 to the patient's chest wall, variations in the composition and density of tissue within the breast 52, etc.

[0042] According to federal guidelines, 21 CFR §900.12(b)(8)(ii)(C), which state that "the compression paddles shall be flat and parallel to the breast support and that the compression paddles shall not deflect more than 1.0 cm from parallel at any point on the compression paddle surface while compression is applied," a certain amount of deflection of the compression paddles 28 is acceptable, and thus the mammographic imaging device 12 must provide images of sufficient quality to enable accurate detection of artifacts within the breast 52 to properly diagnose an imaged breast 52 having a non-uniform thickness that reaches the 1.0 cm limit from parallel.

[0043] In order to provide this functionality to the mammographic imaging device 12, a variety of image and / or scatter correction algorithms have been developed for use within and / or in conjunction with the mammographic imaging device 12 that correct images obtained by the mammographic imaging device 12 for thickness inhomogeneities in the imaged breast 52. An example of this type of recombination algorithm is the New Image Reconstruction Algorithm (NIRA) produced by GE Healthcare of Milwaukee, WI, which operates by adding a local estimate of breast thickness in the recombination of the images to account for breast thickness inhomogeneities. Figure 3As shown, the use of an image correction algorithm (e.g., NIRA) enables the mammographic imaging device 12 to enhance an image 100 of a compressed breast 52 having uneven thickness in the anterior-posterior (inclined from the chest wall toward the nipple) or lateral (left to right, or right to left) direction, and produce a corrected image 102 of the compressed breast 52 that enables accurate detection of artifacts 104 within the breast 52 for preparing a correct diagnosis.

[0044] In order to evaluate the ability of the mammographic imaging device 12 and the image correction algorithm (e.g., NIRA) used therewith to accurately detect artifacts and provide images of adequate quality within an imaged breast of non-uniform thickness, it is necessary to employ a breast phantom 200 that effectively simulates the various non-uniform thicknesses of the imaged breast 52. Referring now to Figure 4 and Figure 5 , illustrates a first exemplary embodiment of a breast phantom 200 having a non-uniform thickness. In an exemplary embodiment, the phantom 200 is formed of a monolithic body 202 of suitable tissue equivalent material (TEM) and / or breast tissue equivalent material for simulating a breast 52, such as materials sold by Sun Nuclear / Computer Imaging Reference Systems, Inc. (CIRS) of Norfolk, VA, such as a Digital Breast Tomosynthesis QC Phantom, a Contrast Enhanced Spectral Mammography Phantom, and / or a Model 020BR3D Breast Imaging Phantom. The body 202 is formed of breast tissue equivalent material in various ratios of glandular and adipose tissue, such as a 50 / 50 ratio of glandular and adipose tissue, and includes a plurality of test plugs 204 disposed therein. The plurality of plugs 204 are formed to have different concentrations of iodine therein to simulate various levels of iodine uptake in breast tissue during a contrast enhanced mammography imaging procedure performed using the mammography imaging device 12. For example, four plugs 204 may be formed to have a thickness of 0.2 mg / cm 2 , 0.5mg / cm 2 , 1.0mg / cm 2 and 2.0mg / cm 2 The body 202 may be provided with an iodine concentration of at least about 100% greater than or equal to ...

[0045] The maximum overall thickness of the breast phantom 200 may be selected to be in the range of 10 mm to 100 mm in order to effectively simulate the various sizes and thicknesses of the breast 52 to be imaged by the mammographic imaging device 12 for testing the mammographic imaging device 12 and the image correction algorithms deployed thereon across the entire practical range of breast sizes, thicknesses and / or densities and / or shapes. In addition, other alternative breast equivalent materials may be utilized to form the body 202, such as suitable plastic materials, including but not limited to polymethylmethacrylate (PMMA), nylon, polyethylene, and acrylonitrile-butadiene-styrene (ABS).

[0046] In addition, the body 202 is formed with a top surface 212 having an angle or bevel 214 relative to the flat bottom surface 216 of the body 202. The difference in thickness of the phantom 200 across the body 202 produced by the bevel 214 of the top surface 212 can be within a range of up to 1.0 cm, with an effective acceptable limit for deflection of the compression paddle 28 being considered uniform compression. Furthermore, the bevel 214 of the top surface 212 can extend across the top surface 212 in the anterior-posterior direction to simulate uneven thickness of the breast compressed for a cranial-caudal (CC) view of the breast 52 in the phantom 200, or the bevel 214 of the top surface 212 can extend across the top surface 212 in a lateral direction (from left to right or from right to left) to simulate uneven thickness of the breast compressed for a mediolateral oblique (MLO) view of the breast 52 in the phantom 200, or a combination thereof. Figure 4 and Figure 5 In the illustrated exemplary embodiment, the ramp 214 extends across the top surface 212 and is bounded by the circular peripheral surface 210. Thus, in the illustrated exemplary embodiment, the selected non-uniform thickness for the phantom 200 is provided by the top surface 212 between the opposing sides of the phantom 200, without including the circular surface 210. In addition, the material used to form the body 202 is non-compressible, e.g., rigid, such that when used to evaluate the mammographic imaging device 12 and the image correction algorithm deployed or illustrated thereon, the phantom 200 does not change shape when the phantom 200 is compressed between the compression paddle 28 and the compression surface 50 of the mammographic imaging device 12. With this aspect of the phantom 200, the non-uniform thickness of the phantom 200 is fully repeatable in multiple test or evaluation settings used to effectively evaluate and determine the image quality of the mammographic imaging device 12.

[0047] In alternative embodiments of the phantom 200, the angle or bevel 214 of the top surface 212 may be formed to provide the body 202 with a non-uniform thickness of between about 0.0 cm and about 1.0 cm (such as between about 0.10 cm and 0.90 cm, or between about 0.25 cm and about 0.75 cm) across the length L or width W of the phantom 200, including a non-uniform thickness of about 0.50 cm.

[0048] refer to Figures 6 to 9 In another exemplary embodiment shown, the phantom 300 may be formed of a plurality of separate parts, including a bottom portion 302, a target portion 304, a texture portion 306, and a top portion 308, which are assembled to form the phantom 300. The bottom portion 302 and the texture portion 306 are formed of suitable breast equivalent materials to simulate adipose and glandular breast tissue, such as those previously described. In addition, the bottom portion 302 has a rounded peripheral edge 305 to simulate the actual shape of a compressed breast. The target portion 304 is also formed of a suitable breast equivalent material but with a test plug 310 having a varying iodine concentration formed therein, and / or is formed of a glandular tissue equivalent material to simulate a lesion, as previously described. In addition, one or more texture portions 306 may be formed to provide an enhancement to the testing capabilities of the phantom 330, such as by forming the texture portion 306 of half 100% adipose material and half 100% glandular material to test iodine separation from background over a wide range of densities.

[0049] Each of the bottom portion 302, texture portion 304, and target portion 306 is formed with a flat bottom surface 312, a flat top surface 314, and a vertical rear surface 322, so that the portions 302, 304, and 306 can be as Figure 6 and 7 304, 306, and 308 to form the phantom 300. The portions 302, 304, 306, and 308 and at least the portion 308 are formed of a non-compressible (e.g., rigid) material such that the phantom 300 does not change shape when the phantom 300 is compressed between the compression paddle 28 and the compression surface 50 of the mammographic imaging device 12 when used to evaluate the mammographic imaging device 12 and the image and / or scatter correction algorithms deployed or exemplified thereon. With this aspect of the phantom 300 and the components 302, 304, 306, and 308, the non-uniform thickness of the phantom 300 in any of the various configurations for the portions 302, 304, 306, 308 is fully repeatable in multiple test or evaluation settings for effectively evaluating and determining the image quality of the mammographic imaging device 12.

[0050] The top portion 308 is also formed of breast equivalent tissue, but as Figure 6As shown in the exemplary embodiment of FIG. 8 , the top portion 308 is formed with a flat lower surface 316 and a flat vertical surface 324, and the flat lower surface can be aligned and / or positioned on the flat top surface 314 of any of the bottom portion 302, the texture portion 304, and the target portion 306 depending on the specific configuration of the phantom 300. Opposite the flat lower surface 316, the top portion 308 includes an inclined upper surface 318. The inclined upper surface 318 is formed similar to the top surface 212 of the phantom 200, so that the inclined upper surface 318 provides a thickness difference of the top portion 308 between about 0.0 cm and about 1.0 cm over the length L or width W of the top portion 308. The top portion 308 also includes a curved peripheral edge 320 that approximates an actual curve on the edge of the breast simulated by the phantom 300. In addition, the direction of the slope on the upper surface 318 can be as shown in FIG. Fig. 8A Oriented in the front / rear direction as shown, or as Figure 8B and 8C The illustration is oriented in one of the transverse directions, ie, from left to right or from right to left.

[0051] Watch now Fig. 9 , the phantom 300 can be formed from a variety of different combinations of parts 302, 304, 306, and 308 to form the phantom 300. Since the target part 304 and the top part 308 including the inclined upper surface 318 are the only required components of the phantom 300, the additional layer used to provide the phantom 300 with a desired thickness can be composed of different numbers of other parts. In order to increase the ease of construction of the phantom 300, for each type of part 302, 304, 306 and 308, each of the parts 302, 304, 306 can be formed to have a uniform thickness, or for all parts 302, 304, 306 to be formed to have the same uniform thickness, such as a thickness of 10 mm. In addition, during the process of forming the body model 300, the parts 302, 304, 306 and 308 are not fixed to each other, but can be aligned and maintained in alignment with each other in any suitable manner, such as by an external alignment device (not shown) engaged with each of the layered parts 302, 304, 306, 308, such as by a protrusion (not shown) formed on the rear vertical surface 322, 324 of each of the parts 302, 304, 306, 308, which is inserted into a complementary groove (not shown) in the external alignment device.

[0052] Still reference Fig. 9In the exemplary embodiments, to construct an exemplary 30 mm thick phantom 300, a single texture layer 304, a single target layer 306, and a top layer 308 can be arranged in an aligned and stacked configuration. Additionally, to construct an exemplary 50 mm thick phantom 300, a single bottom portion 302, a single target portion 304, a pair of texture portions 306, and a top portion 308 can be arranged in an aligned and stacked configuration. Additionally, to construct an exemplary 80 mm thick phantom 300, a single bottom portion 302, a single target portion 304, five (5) texture portions 306, and a top portion 308 can be arranged in an aligned and stacked configuration. In each of the exemplary embodiments, the thickness of the top portion 308 is determined by the thickest portion of the top portion 308, as defined by the high side of the inclined upper surface 318.

[0053] It should be understood that the aforementioned compositions, devices and methods of the present disclosure are not limited to specific embodiments and methods, as these may vary. It should also be understood that the terms used herein are only for the purpose of describing specific exemplary embodiments, and are not intended to limit the scope of the present disclosure, which will only be limited by the appended claims.

Claims

1. A mammography phantom (200), comprising: a. a body (202) of uneven thickness formed of a breast equivalent material, the body comprising an inclined upper surface (212); and b. A plurality of test plugs (204) disposed within the body (202).

2. The mammographic phantom (200) of claim 1, wherein the non-uniform thickness body (202) is formed of a breast tissue equivalent material.

3. The mammographic phantom (2000) of claim 1, wherein the non-uniform thickness body (202) has a thickness difference of between about 0.0 cm and 1.0 cm throughout the body (202).

4. The mammographic phantom (200, 300) of claim 1, wherein the body (200) comprises a plurality of separable parts (302, 304, 306, 308).

5. The mammographic phantom (200, 300) of claim 4, wherein the plurality of detachable portions (302, 304, 306, 308) comprises: a. a top portion (308), the top portion comprising an inclined upper surface (318); and b. A target portion (306) comprising a plurality of test plugs (310) therein.

6. The mammographic phantom (200, 300) of claim 5, wherein the plurality of portions (302, 304, 306, 308) further comprises at least one textured portion (306).

7. The mammographic phantom (200, 300) of claim 5, wherein the plurality of sections (302, 304, 306, 308) further comprises a bottom section (302).

8. The mammographic phantom (200) of claim 5, wherein the top portion (308) has a thickness difference across the top surface of between 0.0 cm and 1.0 cm.

9. The mammographic phantom (200) of claim 1, wherein the inclined upper surface (212) is oriented in an anterior / posterior direction.

10. The mammographic phantom (200) of claim 1, wherein the inclined upper surface (212) is oriented in a transverse direction.

11. A top portion (308) for a breast phantom (200, 300), the top portion (308) comprising a non-uniform thickness body having an inclined upper surface (318).

12. The top portion (308) of claim 11, wherein the body is formed of a rigid breast equivalent material.

13. The top portion (308) of claim 11, wherein the inclined upper surface (318) is oriented in a front / rear direction.

14. The top portion (308) of claim 11, wherein the inclined upper surface (318) is oriented in a transverse direction.

15. The top portion (308) of claim 11, wherein the top portion (308) has a thickness difference across the top surface (318) of between 0.0 cm and 1.0 cm.

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