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Technical Developments |
1 From the Division of Diagnostic Imaging (W.T.Y., G.J.W., A.C.K., P.J.D.), Department of Biostatistics (M.M.J.), Division of Cancer Medicine (M.B.C.), and Division of Surgery (K.K.H.), University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 57, Houston, TX 77030. From the 2002 RSNA scientific assembly. Received January 16, 2003; revision requested March 26; final revision received July 21; accepted August 22. Address correspondence to W.T.Y. (e-mail: wyang@di.mdacc.tmc.edu).
| ABSTRACT |
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© RSNA, 2004
Index terms: Breast, biopsy, 00.1261 Breast neoplasms, localization, 00.1261 Breast radiography, 00.112, 00.1215 Breast radiography, comparative studies, 00.112, 00.1215 Radiography, digital, 00.1215
| INTRODUCTION |
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Recently, whole-breast digital imaging systems have been introduced, and flat-panelbased digital x-ray imaging systems have become commercially available for general radiography applications. The first commercially available Food and Drug Administrationapproved full-field digital mammography unit, Senographe (GE Medical Systems, Milwaukee, Wis), involves use of an amorphous thallium-doped silicon cesium iodide detector. The Senographe detector incorporates active-matrix arrays of integrated electronic circuits and amorphous silicon thin-film transistors that are deposited on large-area glass substrates.
Results of previous studies have shown that, as compared with screen-film mammography systems, flat-panelbased detectors generally have a substantially higher detective quantum efficiency, which may lead to improved microcalcification detection and better low-contrast performance in general (4,5). This performance improvement has been evaluated and investigated with perception studies involving relevant diagnostic tasks (6,7). A recent comparison of full-field digital mammography with screen-film mammography for cancer detection revealed no difference in cancer detection and indicated that the use of full-field digital mammography resulted in fewer patient recalls than did the use of screen-film mammography (8,9).
We hypothesized that digital mammography systems improve efficiency because delays due to film processing are eliminated and technologists can verify positioning and check image quality on a monitor within seconds after an exposure. Thus, the amount of time that a womans breast is in compression is reduced, as is the overall procedure time. The purpose of our study was to determine whether full-field digital mammography requires less, more, or as much procedure time as screen-film mammography for needle localization of breast lesions prior to excisional biopsy.
| Materials and Methods |
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Eighty patients underwent needle localization with screen-film mammographic guidance that was provided with a DMR plus unit (GE Medical Systems), and 78 patients underwent needle localization with full-field digital mammographic guidance that was provided with a Senographe unit. The screen-film system used was the MinR-2000 screen and MinR-2000 film combination (Eastman Kodak, Rochester, NY). Hard-copy screen-film mammograms were processed with a Kodak X-OMAT Multiloader 300 Processor (Eastman Kodak). Soft-copy full-field digital mammograms were read at a 38 x 28-cm M20L acquisition workstation monitor (Image Systems, Minnetonka, Minn) with a matrix of 1,280 x 1,024 pixels, yielding a pixel size of approximately 28 µm for display.
The patients were assigned to the two groups in consecutive cohorts before and after the installation of a full-field digital mammography unit at our institution. Through 2000, prior to the availability of full-field digital mammography, all patients were assigned to the screen-film mammography group. Once the full-field digital mammography unit became available, all subsequent patients were assigned to the full-field digital mammography group. All needle localization procedures at our institution were performed with full-field digital mammography from that point forward. Although patient assignment was not randomized for this study, we believe that there was no selection bias in that all patients were assigned consecutively to a single group at the same institution during a defined time period. The protocol for needle localization was identical with both full-field digital and screen-film mammography. The median patient age was 54 years in both the full-field digital mammography group (age range, 2876 years) and the screen-film mammography group (age range, 2678 years).
Data Collection
Data on mammographically guided needle localization procedure times were collected for all patients. The technologist who performed the procedure recorded these data. Data collection was performed by using soft-copy full-field digital mammography and hard-copy screen-film mammography. Time A was defined as the time from the patients entry into the room to the time that the lesion was appropriately positioned in the field so that needle localization could be performed. Time B was designated as the time from when the first image was acquired to the time when the last image was acquired. Needle localization was performed during time B. The total procedure time was designated as time A + time B.
Additional information collected for each patient included the number of each lesion type described above. The sizes of the individual masses and calcification clusters that were targeted were recorded. Lesions were categorized into the following three groups according to size: lesions smaller than 1 cm, lesions between 1 and 2 cm in size, and lesions larger than 2 cm. For patients with multiple lesions, the largest lesion was used for the per-patient analysis of lesion size. The location of each lesion was categorized as being in the upper or the lower half of the breast or along the 3-oclockto9-oclock axis. The number of needles used per case was recorded. Each procedure involved one radiologist and one technologist, and the names and experience levels of the radiologist and technologist performing each procedure were recorded. A total of eight different radiologists (including G.J.W., A.C.K., and P.J.D.) and 14 different technologists were involved in the needle localization procedures.
Statistical Analysis
Regression modeling was performed to assess the effect of mammographic guidance method on procedure time while simultaneously adjusting for other significant covariates. By using the backward selection technique, statistically nonsignificant variables were removed one at a time to produce a final model for which all statistically significant effects were defined as those with P values of less than .10. To determine the effect of mammographic method on needle placement and total procedure time for all lesions, the initial regression model included as independent variables the method of mammography; lesion type, size, and location; the number of needles used; the number of lesions; and the individual radiologist and technologist. Similarly, to study the effect of type of mammography on positioning time for all lesions, the initial regression model included method of mammography; lesion type, size, and location; and the individual radiologist and technologist. All statistical analyses were performed by using SAS software release 8.1 (SAS Institute, Cary, NC).
| Results |
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| Discussion |
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In our experience, changing from screen-film mammography to full-field digital mammography significantly decreased needle localization procedure time. While the total procedure time savings of approximately 8 minutes resulting from the use of full-field digital rather than screen-film mammographic guidance for needle localization may not be a large enough time reduction to substantially affect workflow in facilities where needle localization is not performed in great volume, the use of full-field digital mammography resulted in a significant time reduction in our facility, where up to three needle localization procedures are performed each morning and many procedures involve bracketing the lesion with multiple needles. Although the time saved during each procedure is relatively small, the time reduction occurs while the patient remains stationary with the breast in compression. Thus, the use of full-field digital mammography may also potentially contribute to a substantial reduction in patient discomfort.
To the best of our knowledge, results of no similar comparison studies of needle localization procedure time that involved the use of full-field digital mammography have been reported in the literature. The amount of time saved in our study was not as great as that observed with use of a small-field-of-view digital system in a study in which that system was compared with screen-film mammography for needle localization (3). Dershaw et al (3) observed a 50% reduction in needle localization procedure time with use of a prototype small-field-of-view (5 x 5 cm) digital mammography unit.
With screen-film mammography units, stereotactic biopsy has been reported to take 2050 minutes (1012), whereas with digital units that are used with patients in the prone position, stereotactic biopsies have been reported to take 1520 minutes (13). Comparative studies in which investigators evaluated the effect of use of full-field digital versus screen-film mammography on the accuracy of core biopsy of microcalcifications performed with upright stereotactic guidance revealed that biopsy with full-field digital mammography had a significantly higher success rate for accurately obtaining calcificationseven in lesions with fewer calcificationsas well as improved sensitivity in the diagnosis of ductal carcinoma in situ (10,11).
Most of the time saved in this study appeared to come from the speed involved in displaying digital images (15 seconds per image) rather than processing films (3 minutes per image). Perhaps the improved time efficiency occurred because there is no film development time with full-field digital mammography systems. Compared with the time required to perform needle localization with screen-film mammography systems, 810 minutes can be saved per needle localization procedure when full-field digital mammography systems are used. In our study, the varying skill levels of the multiple individuals who performed needle localizationranging from trainees to experienced breast imagersalso had an effect on the overall total procedure time. Additionally, multiple patient-related factors that play an important role in the time required for needle localization, such as the time to explain the procedure to the patients and the time for preparation of equipment and supplies, cannot be made more time-efficient by using a full-field digital mammography unit.
Digital mammograms can be presented on laser-printed film or at a high-spatial-resolution computer workstation, also known as a soft-copy display system (13). Currently, only cathode ray tube technology supports the requirements for soft-copy display of digital mammograms in that it can enable the display of mammograms completely on the monitors at full spatial resolution. The pixel size of approximately 28 µm with our acquisition workstation monitor was not a limiting factor for system resolution in this study. Instead, the 100-µm detection element of the full-field digital mammography unit was a limiting factor and may have affected the display of microcalcifications in our study. The efficiency of needle localization in the targeting of subtle calcifications may be improved through the application of image processing software to increase the conspicuity of calcifications nearly instantaneously.
Further limitations of this study included the relatively small study population and the multiple potentially significant covariates of different patients, lesion types, and radiologists and technologists performing the procedures. Although lesion type and individual technologist were not found at multivariate regression analysis to be significant variables in determining procedure time in this study, the individual radiologist performing each procedure did significantly affect procedure time. At the time of this study, there were eight radiologists of varying skill and experience performing needle localization at our institution, a teaching hospital, as well as less-experienced rotating fellows and residents. A further limitation was that data on the number of exposures and the number of films obtained per needle localization procedurepotentially significant variableswere not collected during the study period and thus could not be analyzed in this study. Similarly, breast density, a factor that may potentially affect procedure time, was not compared between the two patient groups.
In conclusion, as digital technology continues to improve and digital mammography becomes less expensive, further study is needed to determine whether the use of digital mammography will contribute substantially to making needle localization procedures more time efficient.
| FOOTNOTES |
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Author contributions: Guarantors of integrity of entire study, W.T.Y., G.J.W.; study concepts, G.J.W., A.C.K., K.K.H.; study design, W.T.Y., G.J.W., M.M.J., K.K.H.; literature research, W.T.Y., G.J.W., M.M.J., M.B.C.; clinical studies, G.J.W., A.C.K., K.K.H., P.J.D.; data acquisition, W.T.Y., G.J.W., M.B.C., A.C.K., K.K.H., P.J.D.; data analysis/interpretation, W.T.Y., M.M.J., M.B.C., P.J.D.; statistical analysis, W.T.Y., M.M.J.; manuscript preparation, W.T.Y., M.M.J., G.J.W.; manuscript definition of intellectual content, W.T.Y., G.J.W.; manuscript editing, revision/review, and final version approval, all authors
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