Physical Address
304 North Cardinal St.
Dorchester Center, MA 02124
Mammography is one of the most technically challenging areas of radiography, requiring high spatial resolution, excellent soft-tissue contrast, and low radiation dose. It is particularly challenging in denser breasts because of the similar attenuation coefficients of breast cancers and fibroglandular tissues. The Digital Mammographic Imaging Study Trial (DMIST) and other recent studies have shown that digital mammography offers improved cancer detection compared with screen-film mammography (SFM) in women with dense breasts ( ). As of March 2015, 96% of the mammography units in the United States are digital units, and some sites are using digital breast tomosynthesis (DBT) systems for screening and diagnostic mammography. Computer-aided detection (CAD) systems specific to mammography are also in common use.
Randomized controlled trials (RCTs) of women invited to mammography screening conducted between 1963 and 2000 based on SFM have shown that early detection and treatment of breast cancer have reduced the proportion of late-stage breast cancers and led to a 20% to 30% decrease in breast cancer mortality among these women. More recent observational studies of screening programs in Europe have shown that screening mammography reduces breast cancer mortality by 38% to 48% among women screened compared with unscreened women (Broeders et al., 2012). A similar observational study in Canada showed breast cancer mortality reduced by 44% among screened women aged 40 to 49, 40% in screened women aged 50 to 59, 42% in screened women aged 60 to 69, and 35% in screened women aged 70 to 79 compared with unscreened women ( ). The different mammography screening recommendations of several major organizations are shown in Box 1.1 (Lee et al., 2010; Oeffinger et al., 2015; Siu, 2016).
American College of Radiology and Society of Breast Imaging: Annual screening starting at age 40 and continuing until a woman’s life expectancy is less than 5-7 years
American Cancer Society: Annual screening ages 45-54, then biennial screening until a woman’s life expectancy is less than 10 years, with the option to begin annual screening at age 40 and to continue annual screening beyond age 54.
United States Preventive Services Task Force: Biennial screening ages 50-74.
In all of these studies, image quality was demonstrated to be a critical component of early detection of breast cancer. To standardize and improve the quality of mammography, in 1987 the American College of Radiology (ACR) started a voluntary ACR Mammography Accreditation Program. In 1992, the U.S. Congress passed the Mammography Quality Standards Act (MQSA; P.L. 102-539), which went into effect in 1994 and remains in effect with reauthorizations in 1998, 2004, and 2007. The MQSA mandates requirements for facilities performing mammography, including equipment and quality assurance requirements, as well as personnel qualifications for physicians, radiologic technologists, and medical physicists involved in the performance of mammography in the United States ( Box 1.2 ).
Congressional act to regulate mammography
Regulations enforced by the Food and Drug Administration (FDA) require yearly inspections of all U.S. mammography facilities
All mammography centers must comply; noncompliance results in corrective action or closure
Falsifying information submitted to the FDA can result in fines and jail terms
Regulations regarding equipment, personnel credentialing and continuing education, quality control, quality assurance, and day-to-day operations
This chapter outlines the basics of image acquisition using SFM, digital mammography, and DBT. It reviews the quality assurance requirements for mammography stipulated by the MQSA and also describes the essentials of CAD in mammography.
Mammography is performed on specially designed, dedicated x-ray machines using either x-ray film and paired fluorescent screens (SFM) or digital detectors to capture the image. All mammography units are comprised of a rotating anode x-ray tube with matched filtration for soft-tissue imaging, a breast compression plate, a moving grid, an x-ray image receptor, and an automatic exposure control (AEC) device that can be placed under or detect the densest portion of the breast, all mounted on a rotating C-arm ( Fig. 1.1 ). A technologist compresses the patient’s breast between the image receptor and compression plate for a few seconds during each exposure. Breast compression is important because it spreads normal fibroglandular tissues so that cancers can be better seen on the superimposed structured noise pattern of normal breast tissues. It also decreases breast thickness, decreasing exposure time, radiation dose to the breast, and the potential for image blurring as a result of patient motion and unsharpness.
Women worry about breast pain from breast compression and about the radiation dose from mammography. Breast pain during compression varies among individuals and may be decreased by obtaining mammograms 7 to 10 days after the onset of menses when the breasts are least painful. Breast pain is also minimized by taking oral analgesics, such as acetaminophen, before the mammogram or by using appropriately designed foam pads that cushion the breast without adversely affecting image quality or increasing breast dose.
Current mammography delivers a low dose of radiation to the breast. The most radiosensitive breast tissues are the epithelial cells, which, along with connective tissues, make up fibroglandular elements. The best measure of breast dose is mean glandular dose, or the average absorbed dose of ionizing radiation to the radiosensitive fibroglandular tissues. The mean glandular dose received by the average woman is approximately 2 mGy (0.2 rad) per exposure or 4 mGy (0.4 rad) for a typical two-view examination. Radiation doses from digital mammography exposures tend to be 20% to 30% lower than those from SFM. Radiation doses to thinner compressed breasts are substantially lower than doses to thicker breasts.
The main patient risk from mammographic radiation is the possible induction of breast cancer 5 to 30 years after exposure. The estimated risk of inducing breast cancer is linearly proportional to the radiation dose and inversely related to age at exposure. The lifetime risk of inducing a fatal breast cancer as a result of two-view mammography in women aged 45 years old at exposure is estimated to be about 1 in 100,000 ( ). For a woman aged 65 at exposure, the risk is less than 0.3 in 100,000. The benefit of screening mammography is the detection of breast cancer before it is clinically apparent. The likelihood of an invasive or in situ cancer present in a woman screened at age 45 is about 1 in 500. The likelihood that the cancer would be fatal in the absence of mammography screening is about 1 in 4, and the likelihood that screening mammography will convey a mortality benefit is 15% (RCT estimate for women aged 40–49) to about 45% (observational study estimate). Hence, the likelihood of screening mammography saving a woman’s life at this age is about 1 in 4400 to 1 in 13,000, yielding a benefit-to-risk ratio of 8:1 to 23:1. For a woman aged 65 at screening, the likelihood of a mortality benefit from mammography is about 1 in 2000 to 1 in 4000 (assuming a 25% to 50% mortality benefit), yielding a benefit-to-risk ratio of approximately 90:1 to 180:1. Screening mammography is only effective when regular periodic exams are performed.
The generator for a mammography system provides power to the x-ray tube. The peak kilovoltage (kVp) of mammography systems is lower than that of conventional x-ray systems, because it is desirable to use softer x-ray beams to increase both soft-tissue contrast and the absorption of x-rays in the image receptor. Low kVp is especially important for SFM, in which screen phosphor thickness is limited to minimize image blur. Typical kVp values for mammography are 24 to 32 kVp for molybdenum (Mo) targets and 26 to 35 kVp for rhodium (Rh) or tungsten (W) targets. A key feature of mammography generators is the electron beam current (milliampere [mA]) rating of the system. The higher the mA rating, the shorter is the exposure time for total tube output (milliampere second [mAs]). A compressed breast of average thickness (5 cm) requires about 150 mAs at 26 kVp to achieve proper film densities in SFM. If the tube rating is 100 mA (typical of the larger focal spots used for nonmagnification mammography), the exposure time would be 1.5 seconds. A higher output system with 150-mA output would cut the exposure time to 1 second for the same compressed breast thickness and kVp setting. Because of the wide range of breast thicknesses, exposures require mAs values ranging from 10 to several hundred mAs. Specifications for generators are listed in Box 1.3 .
Provide 24–32 kVp, 5–300 mA
Half-value layer between kVp/100 + 0.03 and kVp/100 + 0.12 (in millimeters of aluminum) for Mo/Mo anode/filter material
Average breast exposure is 26–28 kVp (lower kVp for thinner or fattier breasts, higher kVp for thicker or denser breasts)
Screen-film systems deliver an average absorbed dose to the glandular tissue of the breast of 2 mGy (0.2 rad) per exposure
Mo, molybdenum.
The most commonly used anode/filter combination is Mo/Mo consisting of an Mo anode (or target) and an Mo filter (25–30 μm thick). This is used for thinner compressed breasts (<5 cm thick). Most current manufacturers also offer an Rh filter to be used with the Mo target (Mo/Rh), which produces a slightly more penetrating (harder) x-ray beam for use with thicker breasts. Some manufacturers offer other target materials, such as Rh/Rh, which is an Rh target paired with an Rh filter, and a W target paired with a Rh filter (W/Rh or with an aluminum [Al] filter [W/Al]). These alternative anode/filter combinations are designed for thicker (>5 cm) and denser breasts. Typically, higher kVp settings are used with these alternative target/filter combinations to create a harder x-ray beam for thicker breasts, because fewer x-rays are attenuated with a harder x-ray beam ( Box 1.4 ). One of the best parameters to measure the hardness or penetrating capability of an x-ray beam is the half-value layer (HVL), which represents the thickness of Al that reduces the x-ray exposure by one-half. The harder the x-ray beam, the higher is the HVL. The typical HVL for mammography is 0.3 to 0.5 mm of Al. The Food and Drug Administration (FDA) requires that the HVL for mammography cannot be less than kVp/100 ± 0.03 (in millimeters of Al), so that the x-ray beam is not too soft (ie, does not contain too many low-energy x-rays that contribute to breast radiation dose but not to image contrast because they are all absorbed in breast tissue). For example, at 28 kVp the HVL cannot be less than 0.31 mm of Al. There is also an upper limit on the HVL that depends on the target–filter combination. For Mo/Mo, the HVL must be less than kVp/100 +0.12 (in mm of Al); thus, for 28 kVp, the HVL must be less than 0.4 mm of Al.
Mo/Mo
Mo/Rh
Rh/Rh
W/Rh, W/Ag, or W/Al
Ag, silver; Al, aluminum; Mo, molybdenum; Rh, rhodium; W, tungsten.
The usual mammography focal spot size for standard contact (ie, nonmagnification) mammography is typically 0.3 mm. Magnification mammography requires a smaller focal spot, (about 0.1 mm) to reduce penumbra (geometric blurring of structures in the breast produced because the breast is closer to the x-ray source and farther from the image receptor to produce greater “geometric” magnification). The effect of focal spot size on resolution in the breast is tested by placing a line pair (lp) pattern in the location of the breast at a specific distance (4.5 cm) from the breast support surface. For SFM, the larger 0.3-mm mammography focal spot used for standard, contact mammography should produce an image that resolves at least 11 lp/mm when the lines of the test pattern run in the direction perpendicular to the length of the focal spot (this measures the blurring effect of the length of the focal spot) and at least 13 lp/mm when the lines run parallel to the focal spot (measuring the blurring effect of the width of the focal spot). Thus, although the SFM image receptor can resolve 18 to 21 lp/mm, the geometry of the breast in contact mammography and the finite-sized larger focal spot reduce the limiting spatial resolution of the system to 11 to 15 lp/mm in the breast . The limiting spatial resolution of digital mammography systems is less (5–10 lp/mm), caused by pixelization of the image by the digital image receptor. In digital, a line is 1 pixel width, and a line pair is 2 pixels. For example, for a digital detector with 100-micron (0.1-mm) pixel size or pitch (the center-to-center distance between adjacent pixels), a line pair consists of 2 pixels or 200 microns (0.2 mm). Therefore, one can fit five line pairs (at 0.2 mm each) into a 1-mm length, or the detector has a limiting spatial resolution of 5 lp/mm. By similar reasoning, a digital detector with 50-micron pixels has a limiting spatial resolution of 10 lp/mm.
The x-ray tube and image receptor are mounted on opposite ends of a rotating C-arm to obtain mammograms in almost any projection. The source-to-image receptor distance (SID) for mammography units must be at least 55 cm for contact mammography. Most systems have SIDs of 65 to 70 cm.
Geometric magnification is achieved by moving the breast farther from the image receptor (closer to the x-ray tube) and switching to a small focal spot, about 0.1 mm in size ( Fig. 1.2 ). Placing the breast halfway between the focal spot and the image receptor (see Fig. 1.2B ) would magnify the breast by a factor of 2.0 from its actual size to the image size because of the divergence of the x-ray beam. The MQSA requires that mammography units with magnification capabilities must provide at least one fixed magnification factor of between 1.4 and 2.0 ( Table 1.1 ). Geometric magnification makes small, high-contrast structures such as microcalcifications more visible by making them larger relative to the noise pattern in the image (increasing their signal-to-noise ratio [SNR]). Optically or electronically magnifying a contact image, as is done with a magnifier on SFM or using a zoom factor greater than 1 on a digital mammogram, does not increase the SNR of the object relative to the background, because both object and background are increased in size equally. To avoid excess blurring of the image with geometric magnification, it is important to use a sufficiently small focal spot (usually 0.1 mm nominal size) and not too large a magnification factor (2.0 or less). When the small focal spot is selected for geometric magnification, the x-ray tube output is decreased by a factor of 3 to 4 (to 25–40 mA) compared with that from a large focal spot (80–150 mA). This can extend imaging times for magnification mammography, even though the grid is removed in magnification mammography. The air gap between the breast and image receptor provides adequate scatter rejection in magnification mammography without the use of an antiscatter grid.
Mammography Type | Nominal Focal Spot Size (mm) | Source-to-Image Distance (cm) |
---|---|---|
Contact film screen | 0.3 | ≥55 |
Magnification | 0.1 | ≥55 |
Collimators near the x-ray tube control the size and shape of the x-ray beam to decrease patient exposure to tissues beyond the compressed breast and image receptor. In mammography, the x-ray beam is collimated to a rectangular field to match the image receptor rather than the breast contour, because x-rays striking the image receptor outside the breast do not contribute to breast dose. By federal regulation, the x-ray field cannot extend beyond the chest wall of the image receptor by more than 2% of the SID. Thus for a 60-cm SID unit, the x-ray beam can extend beyond the chest wall edge of the image receptor by no more than 1.2 cm.
The compression plate and image receptor assembly hold the breast motionless during the exposure, decreasing the breast thickness and providing tight compression, better separating fibroglandular tissues in the breast ( Fig. 1.3 ). The compression plate has a posterior lip that is more than 3 cm high and usually is oriented at 90 degrees to the plane of the compression plate at the chest wall. This lip keeps chest wall structures from superimposing and obscuring posterior breast tissue in the image. The compression plate must be able to compress the breast for up to 1 minute with a compression force of 25 to 45 lb. The compression plate can be advanced by a foot-controlled motorized device and adjusted more finely with hand controls. Because the radiation dose to the breast is decreased in thinner breasts, breast compression, which thins the breast, also decreases radiation dose.
In SFM, the image receptor assembly holds a screen-film cassette in a carbon-fiber support with a moving antiscatter grid in front of the cassette and an AEC detector behind it (see Fig. 1.3A ). Screen-film image receptors are required to be 18 × 24 cm and 24 × 30 cm in size to accommodate both smaller and larger breasts ( Box 1.5 ). Each size image receptor must have a moving antiscatter grid composed of lead strips with a grid ratio (defined as the ratio of the lead strip height to the distance between strips) between 3.5:1 and 5:1. The reciprocating grid moves back and forth in the direction perpendicular to the grid lines during the radiographic exposure to eliminate grid lines in the image by blurring them out. One manufacturer uses a hexagonal-shaped grid pattern to improve scatter rejection; this grid is also blurred by reciprocation during exposure. Use of a grid improves image contrast by decreasing the fraction of scattered radiation reaching the image receptor. Grids increase the required exposure to the breast by approximately a factor of 2 (the Bucky factor), because of the attenuation of primary, as well as scattered, radiation. Grids are not used with magnification mammography. Instead, in magnification mammography, scatter is reduced by collimation and by rejection of scattered x-rays due to a significant air gap between the breast and image receptor.
Both 18 × 24-cm and 24 × 30-cm sizes are required
A moving grid is required for each image receptor size
The compression plate has a posterior lip >3 cm and is oriented 90 degrees to the plane of the plate
Compression force of 25–45 lb
Paddle advanced by a foot motor with hand-compression adjustments
Collimation to the image receptor and not the breast contour
The AEC system, also known as the phototimer , is calibrated to produce a consistent film optical density (OD) by sampling the x-ray beam after it has passed through the breast support, grid, and cassette. The AEC detector is usually a D-shaped sensor that lies along the midline of the breast support and can be positioned by the technologist closer to or farther from the chest wall. If the breast is extremely thick or inappropriate technique factors are selected, the AEC will terminate exposure at a specific backup time (usually 4–6 seconds or 300–750 mAs) to prevent tube overload or melting of the x-ray track on the anode.
Screen-film cassettes used in mammography have an inherent spatial resolution of 18 to 21 lp/mm. Such resolution is achieved typically by using a single-emulsion film placed emulsion side down against a single intensifying screen that faces upward toward the breast in the film cassette. The single-emulsion film with a single intensifying screen is used to prevent the parallax unsharpness and crossover exposure that occur with double-emulsion films and double-screen systems. One manufacturer has introduced a double-emulsion film with double-sided screens (EV System, Carestream Health, formerly Eastman Kodak Health Group) with a thinner film emulsion and screen on top to minimize parallax unsharpness. Most screen-film processing combinations have relative speeds of 150 to 200, with speed defined as the reciprocal of the x-ray exposure (in units of Roentgen) required to produce an OD of 1.0 above base plus fog (1.15–1.2, because base plus fog OD is 0.15–0.2).
Film processing involves development of the latent image on the exposed film emulsion. The film is placed in an automatic processor that takes the exposed film and rolls it through liquid developer to amplify the latent image on the film, reducing the silver ions in the x-ray film emulsion to metallic silver, resulting in film darkening in exposed areas. The developer temperature ranges from 92°F to 96°F. The film is then run through a fixer solution containing thiosulfate (or hypo ) to remove any unused silver and preserve the film. The film is then washed with water to remove residual fixer, which if not removed can cause the film to turn brown over time. The film is then dried with heated air.
Film processing is affected by many variables, and the most important is developer chemistry (weak or oxidized chemistry makes films lighter and lower contrast), developer temperature (too hot may make films darker, and too cool may make films lighter), developer replenishment (too little results in lighter, lower contrast films), inadequate agitation of developer, and uneven application of developer to films (causing film mottling; Table 1.2 ).
Film too dark | Developer temperature too high Wrong mammographic technique (excessive kVp or mAs) Excessive plus-density control |
Film too light | Inadequate chemistry or replenishment Developer temperature too low Wrong mammographic technique |
Lost contrast | Inadequate chemistry or replenishment Water to processor turned off Changed film |
Film turns brown | Inadequate rinsing of fixer |
Motion artifact | Movement by patient Inadequate compression applied Inappropriate mammographic technique (long exposure times) |
Film viewing conditions must be appropriate ( Fig. 1.4 ). Because mammography viewboxes have high luminance levels (>3000 cd/m 2 [3000 nit]), mammograms should be masked so that no light strikes the radiologist’s eye without passing through the exposed film. Because of high luminance levels film collimation of x-ray exposure should be rectangular and extend slightly beyond the edge of the image receptor so that film is darkened to its edges. Viewbox luminance should be reasonably uniform across all viewbox panels. In addition, the ambient room illumination should be low (<50 lux, and preferably less) to minimize “dazzle glare” from film surfaces. Both viewbox luminance and room illumination should be checked annually by the medical physicist as part of the site quality control program, as specified in the ACR Mammography Quality Control Manual .
In digital mammography, the image is obtained in the same manner as in screen-film mammography, using a compression plate and an x-ray tube, with the screen-film cassette replaced by a digital detector (see Fig. 1.3B ). Digital image acquisition has several potential advantages in terms of image availability, image processing, making annotations ( Fig. 1.5 ), and CAD. One advantage is elimination of the film processor, which eliminates artifacts and image noise added during film processing. The image contrast of digital mammography is different among vendors depending on the digital look-up curve, which governs how digital signals are translated into pixel gray scale values. Figure 1.6 shows digital mammograms that were obtained with two machines from different vendors demonstrating how the image contrast varies.
Digital mammography uses indirect or direct digital detectors. Indirect digital detectors use a fluorescent screen made of materials such as cesium iodide (CsI) to convert each absorbed x-ray to hundreds of visible light photons. Behind the fluorescent material, light-sensitive detector arrays made of materials such as amorphous silicon diodes or charge-coupled devices measure the produced light pixel by pixel. The weak electronic signal measured in each pixel is amplified and sent through an analog-to-digital converter, enabling computer storage of each pixel’s measured detector signal.
Direct digital detectors use detector elements that capture and count x-rays directly, although amplification and analog-to-digital conversion are still applied. Another method to produce digital mammograms involves amorphous selenium. An amorphous selenium plate is an excellent absorber of x-rays and an excellent capacitor, storing the charge created by ionization when x-rays are absorbed. After exposure, an electronic device is used to read out the charge distribution on the selenium plate, which is in proportion to local exposure. This can be done by scanning the selenium plate with a laser beam or by placing a silicon diode array in contact with one side of the plate, with bias voltage applied, to read out the stored charge. Each of these methods allows production of high-resolution digital images.
Another approach to full-field digital mammography (FFDM) is computed radiography (CR), which uses a photostimulable phosphor composed of barium fluorobromide doped with europium (BaFBr:Eu). Computed radiography uses the same dedicated mammography units as SFM, replacing the screen-film cassettes and film processor with CR cassettes (in sizes of 18 × 24 cm and 24 × 30 cm) and a CR processor. The phosphor plate within the CR cassette is used to absorb x-rays just as the screen in a screen-film cassette. Rather than emitting light immediately after exposure (through fluorescence), x-ray absorption in the phosphor causes electrons within the phosphor crystals to be promoted to higher energy levels (through photostimulation). The plate is removed from the cassette in the CR processor and a red laser light scans the phosphor plate point by point, releasing electrons and stimulating emission of a higher energy (blue) light in proportion to x-ray exposure. In conventional x-ray systems, CR phosphor plates have an opaque backing and are read from only one side. In at least one FDA-approved CR system for mammography (Fuji 5000D CR, Fujifilm Medical Systems), the CR cassette base is transparent and light emitted from the plate during laser scanning is read from both sides to increase reading efficiency.
No matter which digital detector is used, its job is to measure the quantity of x-rays passing through the breast, compression plate, grid (in contact mammography), and breast holder. The signal measured in each pixel is determined by the total attenuation in the breast along a given ray.
The choice of an analog-to-digital converter determines how many bits of memory will be used to store the signal for each pixel; the more bits per pixel, the more dynamic range there is for the image, but at a higher digital data storage cost. Specifically, if 12 bits per pixel are used, 2 12 or 4096 signal values can be stored. If 14 bits per pixel are used, 2 14 or 16,384 signal values can be stored. Usually 12- to 14-bit storage per pixel is used. In either case, 2 bytes per pixel are required (8 bits = 1 byte) to store the image. For example, the GE Senographe 2000D and DS digital detectors have 1920 × 2304 pixel arrays, or 4.4 million pixels, requiring 8.8 million bytes (8.8 megabytes; MB) of storage per image. Other FFDM systems require up to 52 MB of storage per image.
Screen-film image receptors used for mammography have a line pair resolution of 18 to 21 lp/mm. To equal this spatial resolution, a digital detector would require 25-micron pixels, which would yield noisier images and pose a storage issue caused by the large data sets required to store those images. FFDM systems have spatial resolutions ranging from 5 lp/mm (for 100-micron pixels) to 10 lp/mm (for 50-micron pixels). In digital mammography systems, it is the size of the pixels, or more correctly their center-to-center distance (pitch), that determines (and limits) the spatial resolution of the imaging chain.
The lower limiting spatial resolution of FFDM systems compared with film is offset by the increased contrast resolution of FFDM systems. Unlike SFM, in which the image cannot be manipulated after exposure and processing, FFDM images can be optimized after image capture by image postprocessing and adjustment of image display. For fixed digital detectors, such as CsI and silicon diode arrays (used by GE) and selenium and amorphous silicon diode arrays (used by Hologic and Siemens), one image-processing step that can minimize image noise and structured artifacts is flat-field correction, or gain correction of each acquired digital image. This is done by making and storing a sensitivity map of the digital detector and using that map to correct all exposures. Typically, slot-scanning devices (such as the older SenoScan digital system, Fischer Medical Systems) and CR systems do not perform flat-field correction of digital images. Beyond this, all digital systems have the ability to process the acquired digital image to minimize or eliminate the signal difference that results from the roll-off in thickness of the breast toward the skin line (thickness equalization); some devices add processing to help enhance the appearance of microcalcifications (eg, GE Premium View and FineView). The window width and window level for all digital images viewed with soft copy display on review workstations can be adjusted, changing the contrast and brightness of the images, respectively, as well as digitally magnifying images.
Another important difference between SFM and FFDM is that screen-film images have a linear relationship between the logarithm of x-ray exposure and film OD only in the central portion of the characteristic curve. In FFDM, there is a linear relationship between x-ray exposure and signal over the entire dynamic range of the detector. Thus digital images (at least their “raw” or “for processing” presentation) do not suffer contrast loss in underexposed or overexposed areas of the mammogram (as long as detector saturation does not occur); instead, they show similar contrast over the full dynamic range of signals. Different manufacturers apply different look-up tables to digital images in transforming them from initially acquired raw or for processing images to processed or for presentation images. These different look-up tables affect the contrast of final presentation digital images. Some, such as Hologic’s linear look-up table, yield higher contrast images, whereas others, such as GE’s sigmoidal look-up table, yield images presented with less contrast and more like screen-film images. In either case, thickness equalization is used to equalize signal differences from the center of the breast to the skin line. FFDM also has the advantage of eliminating the variability and noise added by film processing that is inherent to SFM.
In terms of breast dose, FFDM has a mean glandular dose lower than, or comparable with, the radiation dose of SFM. Results from the American College of Radiology Imaging Network (ACRIN) DMIST found the average single-view mean glandular dose for FFDM to be 1.86 mGy, 22% lower than the average SFM mean glandular dose of 2.37 mGy ( ). Specific manufacturers, especially those using slot-scanning techniques, produce lower doses than SFM. Slot-scanning systems have a narrow slot of detector elements that are scanned under the breast in synchronization with a narrow fan beam of x-rays swept across the breast. This design, although more technically difficult to implement, has the advantage of eliminating the need for a grid to reduce scattered radiation. Scatter is partially eliminated by the narrow slot itself. The absence of a grid reduces the amount of radiation to the breast needed to get the same SNR in the detector. Most full area digital detectors also have demonstrated lower breast doses compared with SFM, especially for thicker breasts.
Once captured and processed, the image data are transferred to a reading station for interpretation on high-resolution (2048 × 2560 or 5-Mpixel) monitors or printed on film by laser imagers (with approximately 40-micron spot sizes, so that film printing does not reduce the inherent spatial resolution of digital mammograms) for interpretation of hardcopy images on film viewboxes or alternators ( Fig. 1.7 ). Digital data can be stored on optical disks, magnetic tapes, picture archiving and communication systems (PACS), or CDs for later retrieval.
The MQSA states that FFDM images must be made available to patients as hardcopy films, as needed, which means the facility must have access to an FDA-approved laser printer for mammography that can reproduce the gray scale and spatial resolution of FFDM images. The images may also be given to the patient on a CD with an image viewer, if this is acceptable to the patient.
A number of studies have evaluated the performance of FFDM compared with SFM for screening asymptomatic women for breast cancer. Early studies showed comparable or slightly worse results (but not statistically significant differences) for receiver operating characteristic (ROC) curve area and sensitivity ( ) or cancer detection rate ( ) of FFDM compared with SFM. Larger studies, however, showed some benefits of FFDM compared with SFM. The ACRIN DMIST paired study ( ) showed no difference overall, but found that FFDM had statistically significantly higher ROC curve areas than SFM for women under age 50, for premenopausal and perimenopausal women, and for women with denser breasts (Breast Imaging Reporting and Data System [BI-RADS] density categories C and D). These findings are supported by who showed in clinical practice in the United States that FFDM had higher, but not necessarily significantly higher, sensitivity than SFM in most age groups, including women 40 to 49, premenopausal and perimenopausal women, and women with extremely dense breasts. The sensitivity of FFDM was significantly higher than for SFM among women aged 40 to 79 who had estrogen receptor–negative cancers, and especially so among women aged 40 to 49 (95% versus 55%; p = 0.007) The Oslo II trial showed that digital mammography had a significantly higher cancer detection rate (5.9 cancers per 1000 women screened) than SFM (3.8 cancers per 1000 women screened) ( ).
Interpretation times for screening exams using FFDM tend to take 1.5 to 2 times longer than screening exams on SFM ( ; ). As of May 2016, 98% of the mammography units in the United States are digital mammography systems. The FDA-approved manufacturers for digital mammography units and their approval dates are listed in Box 1.6 .
GE Senographe 2000D Full Field Digital Mammography (FFDM) System: 1/28/00
Fischer Imaging SenoScan Full Field Digital Mammography (FFDM) System: 9/25/01
Lorad Digital Breast Imager Full Field Digital Mammography (FFDM) System: 3/15/02
Lorad/Hologic Selenia Full Field Digital Mammography (FFDM) System: 10/2/02
GE Senographe DS Full Field Digital Mammography (FFDM) System: 2/19/04
Siemens Mammomat Novation DR Full Field Digital Mammography (FFDM) System: 8/20/04
GE Senographe Essential Full Field Digital Mammography (FFDM) System: 4/11/06
Fuji Computed Radiography Mammography Suite (FCRMS): 7/10/06
Hologic Selenia Full Field Digital Mammography (FFDM) System with a Tungsten target: 11/2007
Siemens Mammomat Novation S Full Field Digital Mammography (FFDM) System: 2/11/09
Hologic Selenia S Full Field Digital Mammography (FFDM) System: 2/11/09
Hologic Selenia Dimensions 2D Full Field Digital Mammography (FFDM) System: 2/11/09
Carestream Directview Computed Radiography (CR) Mammography System: 11/3/10
Siemens Mammomat Inspiration Full Field Digital Mammography (FFDM) System: 2/11/11
Hologic Selenia Dimensions Digital Breast Tomosynthesis (DBT) System: 2/11/11
Philips (Sectra) MicroDose L30 Full-Field Digital Mammography (FFDM) System: 4/28/11
Hologic Selenia Encore Full-Field Digital Mammography (FFDM) System: 6/15/11
Siemens Mammomat Inspiration Pure Full-Field Digital Mammography (FFDM) System: 8/16/11
Planmed Nuance Full-Field Digital Mammography (FFDM) System: 9/23/11
Planmed Nuance Excel Full-Field Digital Mammography (FFDM) System: 9/23/11
GE Senographe Care Full-Field Digital Mammography (FFDM) System: 10/7/11
Fuji Aspire HD Full-Field Digital Mammography (FFDM) System: 9/1/11
Giotto Image 3D-3DL Full-Field Digital Mammography (FFDM) System: 10/27/11
Fuji Aspire Computed Radiography for Mammography (CRM) System: 12/8/11
Agfa Computed Radiography (CR) Mammography System: 12/22/11
Konica Minolta Xpress Digital Mammography Computed Radiography (CR) System: 12/23/11
Fuji Aspire HD-s Full-Field Digital Mammography (FFDM) System: 9/21/12
Fuji Aspire HD Plus Full-Field Digital Mammography (FFDM) System: 9/21/12
Philips MicroDose SI Model L50 Full-Field Digital Mammography (FFDM) System: 2/01/13
iCRco 3600M Mammography Computed Radiography (CR) System: 4/26/13
Siemens Mammomat Inspiration Prime Full-Field Digital Mammography (FFDM) System: 6/11/13
Fuji Aspire Cristalle Full-Field Digital Mammography (FFDM) System: 3/25/14
GE SenoClaire Digital Breast Tomosynthesis (DBT) System: 8/26/14
Siemens Mammomat Inspiration with Tomosynthesis Option (DBT) System: 4/21/15
Siemens Mammomat Fusion: 9/14/15
Digital breast tomosynthesis obtains a set of rapidly acquired low-dose digital projections taken at multiple angles through the compressed breast to reconstruct a stack of high-resolution, mammographic-quality planar images through the entire breast ( Fig. 1.8 ). The reconstructed planes are parallel to the plane of the breast support (perpendicular to the central ray of the x-ray unit) and are spaced every 0.5 mm or 1 mm apart. The technique is similar to the previous technique of linear film tomography, but with one major difference. In film tomography, a full sweep of the x-ray tube resulted in a single planar image through the patient, with tissues in the selected plane in focus while tissues outside that single plane were blurred. In digital tomosynthesis, a single sweep of the x-ray tube and reconstruction of the stored digital data results in a stack of dozens of parallel images through the breast, each image with a single in-focus plane, with blurring of the tissues above and below each focal plane.
The stack of reconstructed in-focus planar images from DBT permits improved visualization of lesion margins and can reveal suspicious lesions with greater clarity than conventional mammography ( Fig. 1.9 ) ( ). This is possible because DBT minimizes structured noise caused by overlapping tissues, which is a significant limitation of conventional two-dimensional (2D) screen-film or digital mammography. DBT images also reduce callbacks for additional imaging by eliminating or reducing the complication of superimposed fibroglandular tissues that can appear suspicious in conventional 2D projection mammography.
Different manufacturers have taken different approaches to DBT in terms of the number of acquired low-dose projections, angular range of the projections, detector types, and scan time. Table 1.3 presents DBT design parameters for four different DBT manufacturers. As of May 2016, three manufacturers (Hologic, GE Healthcare, and Siemens Healthcare) have received FDA approval for clinical use of DBT for screening and diagnostic breast imaging in the United States.
Manufacturer Parameter | GE Healthcare | Hologic | IMS Giotto | Siemens |
---|---|---|---|---|
Tube motion | Step-and-shoot | Continuous | Step-and-shoot | Continuous |
Angular range | 25 degrees | 15 degrees | 40 degrees | 50 degrees |
Number of projections | 9 | 15 | 13 | 25 |
Scan time (s) | 7 | 4 | 12 | 25 |
Detector pixel size for digital breast tomosynthesis | 100 μm | 140 μm a | 85 μm | 85 μm |
Grid | Yes | No | No | No |
Reconstruction algorithm | Iterative | Back-projection | Iterative | Iterative |
A multireader FDA approval study of Hologic DBT by found significantly higher ROC curve areas for two-view DBT added to two-view FFDM compared with FFDM alone. Most clinical studies of DBT have reported similar results, with higher breast cancer detection rates and/or higher sensitivity with two-view DBT added to two-view FFDM, than with FFDM alone. They have also shown significantly lower recall rates with DBT plus FFDM compared with DBT alone. For example, compared the performance of 13,856 screening FFDM studies finding 56 cancers in 2010 to 9499 studies with FFDM plus DBT finding 51 cancers from May 2011 to early 2012. They found that cancer detection rates increased from 4.0 to 5.4 per 1000 screenings ( p = 0.18, not significant), whereas recall rates dropped from 8.7% to 5.5% ( p < 0.001, highly significant), and positive predictive value for recalls increased from 4.7% to 10.1% ( p < 0.001). Similar results were found by in Oslo and by in Italy: significantly higher cancer detection rates and significantly lower false-positive rates with DBT plus FFDM compared with FFDM alone.
Breast radiation doses with DBT added to FFDM are approximately double that of FFDM alone ( ). Recently, however, Hologic has received FDA approval to replace DBT plus FFDM acquisitions with DBT acquisitions in which 2D FFDM (C view) images are synthesized from DBT data, reducing breast radiation doses from two-view DBT with C view images to approximately the same as two-view FFDM. GE’s approach to DBT approved by the FDA was to acquire a DBT mediolateral oblique (MLO) view and 2D craniocaudal (CC) FFDM view of each breast at the same dose as two-view FFDM. GE systems also have the capability to acquire DBT CC views at approximately the same dose as 2D FFDM CC views.
Interpretation times for screening exams using DBT plus FFDM tend to be longer than for FFDM alone by 47% to 102% ( ; ).
The two views obtained for screening mammography are the CC and MLO projections. The names for the mammographic views and abbreviations are based on the ACR BI-RADS, a lexicon system developed by experts for standard mammographic terminology. The first word in the mammographic view indicates the location of the x-ray tube, and the second word indicates the location of the image receptor. Thus a CC view would be taken with the x-ray tube pointing at the breast from the head (cranial) down through the breast to the image receptor in a more caudal (toward the feet) position.
For positioning, the technologist tailors the mammogram to the individual woman’s body habitus to get the best image. The breast is relatively fixed in its medial borders near the sternum and the upper breast, whereas the lower and outer portions of the breast are more mobile. The technologist takes advantage of the mobile lower outer breast to obtain as much breast tissue on the mammogram as possible. One component of ACR Mammography Accreditation is clinical image review in which clinical images are submitted for peer review of one patient with dense breasts and one patient with fatty breasts acquired on each mammography unit every 3 years. To pass ACR accreditation clinical image review, the MLO mammogram must show most of the breast tissue in one projection, with portions of the upper inner and lower inner quadrants partially excluded ( Figs. 1.10 and 1.11 ). Clinical evaluation of the MLO view should show fat posterior to the fibroglandular tissue and a large portion of the pectoralis muscle, which should be convex and extend inferior to the posterior nipple line (PNL; Figs. 1.12 and 1.13 ). The nipple must be in profile on at least one of the two images. The PNL describes an imaginary line drawn from the nipple to the pectoralis muscle or chest wall image edge and perpendicular to the pectoralis muscle. The PNL should intersect the pectoralis muscle in the MLO view in more than 80% of women. The MLO view should show adequate compression, exposure, contrast, and an open inframammary fold ( Fig. 1.14 ), in which both the lower portion of the breast and a portion of the upper abdominal wall should be seen.
To pass ACR clinical image review, the CC view should include the medial posterior portions of the breast without sacrificing the outer portions ( Fig. 1.15 ; see Fig. 1.10 ). With proper positioning technique, the technologist should be able to include the medial portion of the breast without rotating the patient medially by lifting the lower medial breast tissue onto the image receptor. The pectoralis muscle should be seen when possible on the CC view. On the CC view, the PNL extends from the nipple to the pectoralis muscle or the chest wall edge of the image and perpendicular to the pectoralis muscle or image edge. For a given breast, the length of the PNL on the CC view should be within 1 cm of its length on the MLO view.
Although the technologist tries to avoid producing skin folds on the image when possible, they are seen occasionally and sometimes the image needs to be repeated, and other times they may not cause problems for the radiologist reading the image ( Fig. 1.16 ).
described reasons why 1034 mammographic clinical images failed ACR accreditation, which included positioning in 20%, contrast in 13%, labeling in 8%, and noise in 5% at a time when only film-screen mammography was available. They included the deficiencies mentioned previously as reasons for failure and also included these reasons: sagging breast tissue, portions of the breast not visualized, other body parts included on the mammogram, breast positioned too high on the image receptor, motion artifact, poor compression resulting in poor separation of breast tissues, poor contrast or exposure, and unsharpness.
Become a Clinical Tree membership for Full access and enjoy Unlimited articles
If you are a member. Log in here