Effectiveness of a Mobile Mammography Program.

OBJECTIVE: Mobile mammography units have increasingly been used to address patient health care disparities; however, there are limited data comparing mobile units to stationary sites. This study aims to evaluate the characteristics of women who underwent mammography screening in a mobile unit versus those who underwent mammography screening at a cancer center. MATERIALS AND METHODS: In this retrospective study, we analyzed all screening mammography examinations performed in a mobile unit in 2014 (n = 1433 examinations). For comparison, we randomized and reviewed an equivalent number of screening mammography examinations performed at our cancer center in 2014 (n = 1434 examinations). BI-RADS assessment, adherence to follow-up, biopsies performed, cancer detection rate, and sociodemographic variables were recorded. An independent-samples t test was conducted to identify potential differences in age between cancer center patients and mobile unit patients. Chi-square analyses were used to test for associations between location and factors such as health insurance, race, marital status, geographic area, adherence to screening guidelines, recall rate, adherence to follow-up, and cancer detection rates. RESULTS: Patients visiting our cancer center (mean = 57.74 years; SD = 10.55) were significantly older than those visiting the mobile unit (mean = 52.58 years; SD = 8.19; p < 0.001). There was a significant association between location and health insurance status (χ2 = 610.92; p < 0.001) with more uninsured patients undergoing screening in the mobile van (cancer center = 3.70%, mobile unit = 38.73%). There was a significant association between screening location and patient race (χ2 = 118.75, p < 0.001), with more white patients being screened at the cancer center (cancer center = 47.28%, mobile unit = 33.30%), more black patients being screened in the mobile van (cancer center = 49.30%, mobile unit = 54.15%), and more Hispanic patients being screened in the mobile van (cancer center = 1.05%, mobile unit = 6.77%). There was a significant association between location and patient marital status (χ2 = 135.61, p < 0.001), with more married patients screened at the cancer center (cancer center = 49.16%, mobile unit = 38.31%), more single patients screened in the mobile van (cancer center = 25.17%, mobile unit = 34.47%), and more widowed patients being screened at the cancer center (cancer center = 8.09%, mobile unit = 4.47%). There was a significant association between location and geographic area (χ2 = 33.33, p < 0.001), with both locations reaching more urban than rural patients (cancer center = 79.99%, mobile unit = 70.62%). There was a significant association between location and adherence to screening guidelines (χ2 = 179.60, p < 0.001), with patients screened at the cancer center being more compliant (cancer center = 56.90%, mobile unit = 34.47%). Finally, there was a significant association between location and recall rate (χ2 = 4.06, p < 0.001). The cancer center had a lower recall rate (13.32%) than the mobile van (15.98%). Of those patients with BI-RADS 0, there was a significant association between location and adherence to follow-up (χ2 = 22.75, p < 0.001) with patients using the mobile unit less likely to return for additional imaging (cancer center = 2.65%, mobile unit = 17.03%). CONCLUSION: Significant differences were found among patients visiting the cancer center versus the mobile mammography van. The cancer center's population is older and more adherent to guidelines, whereas the mobile mammography population exhibited greater racial and marital diversity, higher recall rate, and lack of adherence to follow-up recommendations. By identifying these characteristics, we can develop programs and materials that meet these populations' needs and behaviors, ultimately increasing mammography screening and follow-up rates among underserved populations.

Changes in Breast Density Reporting Patterns of Radiologists After Publication of the 5th Edition BI-RADS Guidelines: A Single Institution Experience.

OBJECTIVE: The objective of our study was to determine the impact of 5th edition BI-RADS breast density assessment guidelines on density reporting patterns in our clinical practice. MATERIALS AND METHODS: PenRad reporting system was used to collect mammographic breast density data reported by five radiologists: 16,907 density assignments using 5th edition BI-RADS guidelines were compared with 19,066 density assessments using 4th edition guidelines. Changes in the density assessment pattern were noted between the 4th and 5th edition guidelines, and agreement in density distribution was compared using the intraclass correlation coefficient. A chi-square analysis was conducted for each reader to examine the change in the proportion of dense versus nondense assignments and on each category type to examine specific changes in proportion of density assignments from the 4th to the 5th edition. All reported p values are two-sided, and statistical significance was considered at the p < 0.001 threshold. RESULTS: Using the 5th edition, there was an overall 5.0% decrease in fatty assessments (p < 0.001), 2.8% increase in scattered densities (p < 0.001), 2.6% increase in heterogeneously dense (p < 0.001), and 0.4% decrease in extremely dense assessments (p = 0.15). Comparing the dense with nondense categories, there was a 2.3% overall increase in the dense assessments (p < 0.001) using 5th edition guidelines, mainly in the heterogeneously dense category. Two radiologists showed increased dense assessments (p < 0.001) using the 5th edition, and three radiologists showed no change (p = 0.39, 0.67, and 0.76). CONCLUSION: There was an overall increase in the dense assessments using the 5th edition, but individual radiologists in our clinical practice showed a variable adaptation to new guidelines.

Effects of Changes in BI-RADS Density Assessment Guidelines (Fourth Versus Fifth Edition) on Breast Density Assessment: Intra- and Interreader Agreements and Density Distribution.

OBJECTIVE: The objective of our study was to determine intra- and interreader agreements for density assessment using the fifth edition of the BI-RADS guidelines and to compare with those for density assessment using the fourth edition of the BI-RADS guidelines. MATERIALS AND METHODS: Five radiologists assessed breast density four times in 104 mammographic examinations: twice using the fourth edition of the BI-RADS guidelines and twice using the fifth edition. The intra- and interreader agreements for density assessment based on each guideline were determined and compared. The density distribution pattern under each of the four BI-RADS density categories using each guideline was also noted and compared. RESULTS: The intrareader agreement for density assessment using the fifth-edition criteria was lower than that using the fourth-edition criteria (p = 0.0179). The overall intrareader agreement (weighted kappa) using the old criteria was 0.84 (95% CI, 0.80-0.87), and the individual intrareader agreement values in five readers ranged from 0.78 (95% CI, 0.69-0.88) to 0.92 (95% CI, 0.87-0.97). The overall intrareader agreement using the new BI-RADS criteria was 0.77 (95% CI, 0.73-0.81), and the individual intrareader agreement values in five readers ranged from 0.74 (95% CI, 0.64-0.84) to 0.99 (95% CI, 0.98-1.00). The interreader agreement values obtained using the fifth-edition criteria were also lower than those obtained using the fourth-edition criteria (p = 0.006). The overall interreader agreement using the old BI-RADS criteria was 0.65 (95% CI, 0.61-0.69), whereas the overall interreader agreement using the new BI-RADS criteria was 0.57 (95% CI, 0.53-0.61). Overall a higher number of dense assessments were given when the fifth-edition guidelines were used (p < 0.0001). CONCLUSION: Compared with the intra- and interreader agreements obtained using the fourth edition of the BI-RADS guidelines, the intra- and interreader agreements were lower using the fifth-edition guidelines. An increased number of dense assessments were given when the fifth-edition guidelines were used.

Assessing the Relationship of Mammographic Breast Density and Proliferative Breast Disease.

Increased breast density and a history of benign breast biopsy are both considered risk factors for developing breast cancer. Understanding the specifics of these risk factors and their relationship to each other can lead to a better understanding of a patient's propensity for breast cancer development and improved surveillance strategies. We included 245 women who underwent a benign breast biopsy without atypia between October 2011 and June 2013. Biopsies were performed for suspicious calcifications as well as masses and architectural distortion. Lesions biopsied were divided into two groups: calcified and noncalcified lesions. The patient's breast density was assessed on most recent mammogram and was classified using the American College of Radiology BI-RADS density categories. Based on histologic diagnosis, each case was classified as proliferative or nonproliferative breast disease. The median age of the cohort (n = 245) was 55 years (range, 40-84 years). There were 162 (66%) postmenopausal women in the study. A core biopsy was performed for calcifications in 33.5% cases and for noncalcified lesions in 58% cases. In patients with dense breast tissue, an underlying proliferative histology was found significantly more frequently with calcifications (66.7%) as opposed to noncalcified lesions (35.9%) (RR = 2.3 (1.3-4.0); χ(2) = 8.7; p = 0.003). In nondense breast patients, there was no significant difference (RR = 1.1 (0.7-1.8); χ(2) = 0.1; p = 0.738). In the postmenopausal group, women with dense breasts had proliferative histology significantly more frequently than women with nondense breasts (55.3% versus 38.3%; p < 0.05), regardless of the underlying lesion type. Postmenopausal women with dense breasts who underwent a breast biopsy with benign histology had a significantly higher likelihood of having proliferative breast disease, regardless of underlying lesion type. Women with dense breasts also showed proliferative histology significantly more often for calcifications as opposed to noncalcified lesions.

Breast MRI, digital mammography and breast tomosynthesis: comparison of three methods for early detection of breast cancer.

Breast cancer is the most common malignancy in women and early detection is important for its successful treatment. The aim of this study was to investigate the sensitivity and specificity of three methods for early detection of breast cancer: breast magnetic resonance imaging (MRI), digital mammography, and breast tomosynthesis in comparison to histopathology, as well as to investigate the intraindividual variability between these modalities. We included 57 breast lesions, each detected by three diagnostic modalities: digital mammography, breast MRI, and breast tomosynthesis, and subsequently confirmed by histopathology. Breast Imaging-Reporting and Data System (BI-RADS) was used for characterizing the lesions. One experienced radiologist interpreted all three diagnostic modalities. Twenty-nine of the breast lesions were malignant while 28 were benign. The sensitivity for digital mammography, breast MRI, and breast tomosynthesis, was 72.4%, 93.1%, and 100%, respectively; while the specificity was 46.4%, 60.7%, and 75%, respectively. Receiver operating characteristics (ROC) curve analysis showed an overall diagnostic advantage of breast tomosynthesis over both breast MRI and digital mammography. The difference in performance between breast tomosynthesis and digital mammography was significant (p <0.001), while the difference between breast tomosynthesis and breast MRI was not significant (p=0.20).

Cosmetic outcomes for accelerated partial breast irradiation before surgical excision of early-stage breast cancer using single-dose intraoperative radiotherapy.

PURPOSE: Determine cosmetic outcome and toxicity profile of intraoperative radiation delivered before tumor excision for patients with early-stage breast cancer. METHODS AND MATERIALS: Patients age 48 or older with ultrasound-visible invasive ductal cancers <3 cm and clinically negative lymph nodes were eligible for treatment on this institutional review board-approved Phase II clinical trial. Treatment planning ultrasound was used to select an electron energy and cone size sufficient to cover the tumor plus a 1.5- to 2.0-cm circumferential margin laterally and a 1-cm-deep margin with the 90% isodose line. The dose was prescribed to a nominal 15 Gy and delivered using a Mobetron electron irradiator before tumor excision by segmental mastectomy. Physician- and patient-assessed cosmetic outcome and patient satisfaction were determined by questionnaire. RESULTS: From March 2003 to July 2007, 71 patients were treated with intraoperative radiation therapy. Of those, 56 patients were evaluable, with a median follow-up of 3.1 years (minimum 1 year). Physician and patient assessment of cosmesis was "good or excellent" (Radiation Therapy Oncology Group cosmesis scale) in 45/56 (80%) and 32/42 (76%) of all patients, respectively. Eleven patients who received additional whole breast radiation had similar rates of good or excellent cosmesis: 40/48 (83%) and 29/36 (81%), respectively). Grade 1 or 2 acute toxicities were seen in 4/71 (6%) patients. No Grade 3 or 4 toxicities or serious adverse events have been seen. CONCLUSION: Intraoperative radiotherapy delivered to an in situ tumor is feasible with acceptable acute tolerance. Patient and physician assessment of the cosmetic outcome is good to excellent.

Local control following single-dose intraoperative radiotherapy prior to surgical excision of early-stage breast cancer.

BACKGROUND: Multiple partial breast radiotherapy techniques are available. We have previously presented the technical details of our procedure of delivering partial breast irradiation with a single fraction of intraoperative radiotherapy (IORT) targeting the tumor in situ prior to partial mastectomy. This study details our completed, single-institution trial. MATERIALS AND METHODS: An IRB-approved, DSMB-monitored phase II trial was performed with the following inclusion criteria: women age ≥48, ultrasound-visible invasive ductal cancers <3 cm, clinically negative axillary nodes. IORT was delivered using mobile electron irradiator, at least a 1.5-cm radial and 1-cm deep margin; patients received 15 Gy and immediately underwent partial mastectomy. Ipsilateral breast recurrence was classified as true/marginal, elsewhere in the breast or nodal basin. Kaplan-Meier methods were used to estimate survival functions and exact 95% confidence intervals are reported. RESULTS: Between 2003 and 2007, 71 women underwent IORT (median follow-up: 3.5 years). For patients with tumor-involved or close margins, additional therapy was required: 7 patients, total mastectomy; 11, whole breast radiation. Four women experienced invasive ipsilateral breast failures (1 new primary, 3 margin recurrences) for a 3-year local control rate of 49 of 53 (94.8%; 95% confidence interval 92.4% [95% CI] 84.2­98.3%), actuarial three-year in breast recurrence was 8% (95% CI 2­18%), and breast cancer-specific survival was 100%. CONCLUSIONS: Intraoperative radiotherapy delivered to an in situ tumor is feasible, but our local control rate at 3.5 years is concerning. Possible changes to this technique to improve local control rates include better preoperative imaging (MRI), routine intraoperative ultrasound, and improved IORT delivery (larger cone, increased dose).

Comparison of image acquisition and radiologist interpretation times in a diagnostic mammography center.

RATIONALE AND OBJECTIVES: The purpose of this study was to determine the acquisition and interpretation times of screen-film mammography and soft-copy digital mammography in a diagnostic mammography center. MATERIALS AND METHODS: The study was conducted in three phases for patients presenting for clinical diagnostic workup to a mammography clinic. In the first phase, technologist acquisition and processing times and radiologist interpretation time were measured for patients imaged with a screen-film mammographic system. During the second phase of the study, times were measured for patients imaged with a direct radiographic digital mammographic system, with interpretation performed on a soft-copy display system. During the third phase, 3 months after installation of the soft-copy display system, times were measured again for patients imaged on the same direct radiographic digital mammographic system, with interpretation with the same soft-copy system. The same four experienced breast imaging radiologists and seven technologists participated in all phases of the study. All data were entered into a database, and statistical analysis was conducted using weighted linear models and logarithmic transformation. RESULTS: Times were obtained for 295 patients. There were 100 patients each for phases 1 and 2 and 95 patients for phase 3. Diagnostic mammographic acquisition times with processing were 13.02 min/case for screen film (phase 1), 8.16 min/case for digital (phase 2), and 10.66 min/case for digital (phase 3) (P < .001 and P < .0001, respectively). In addition, the radiologist interpretation time for digital mammography in both phases was not significantly different from that for film mammography (P = .2853 and P = .2893, respectively). There was no significant difference between phases 2 and 3 (P = 1.0000). The mean interpretation times were 3.75 min/case for screen film, 2.14 min/case for digital (phase 2), and 2.26 min/case for digital (phase 3). CONCLUSIONS: Digital mammography significantly shortened the acquisition time for diagnostic mammography. There was no significant difference in interpretation time compared to screen-film mammography in a diagnostic mammography setting.

Cancer cases from ACRIN digital mammographic imaging screening trial: radiologist analysis with use of a logistic regression model.

PURPOSE: To determine which factors contributed to the Digital Mammographic Imaging Screening Trial (DMIST) cancer detection results. MATERIALS AND METHODS: This project was HIPAA compliant and institutional review board approved. Seven radiologist readers reviewed the film hard-copy (screen-film) and digital mammograms in DMIST cancer cases and assessed the factors that contributed to lesion visibility on both types of images. Two multinomial logistic regression models were used to analyze the combined and condensed visibility ratings assigned by the readers to the paired digital and screen-film images. RESULTS: Readers most frequently attributed differences in DMIST cancer visibility to variations in image contrast--not differences in positioning or compression--between digital and screen-film mammography. The odds of a cancer being more visible on a digital mammogram--rather than being equally visible on digital and screen-film mammograms--were significantly greater for women with dense breasts than for women with nondense breasts, even with the data adjusted for patient age, lesion type, and mammography system (odds ratio, 2.28; P < .0001). The odds of a cancer being more visible at digital mammography--rather than being equally visible at digital and screen-film mammography--were significantly greater for lesions imaged with the General Electric digital mammography system than for lesions imaged with the Fischer (P = .0070) and Fuji (P = .0070) devices. CONCLUSION: The significantly better diagnostic accuracy of digital mammography, as compared with screen-film mammography, in women with dense breasts demonstrated in the DMIST was most likely attributable to differences in image contrast, which were most likely due to the inherent system performance improvements that are available with digital mammography. The authors conclude that the DMIST results were attributable primarily to differences in the display and acquisition characteristics of the mammography devices rather than to reader variability.

Radiologist evaluation of an X-ray tube-based diffraction-enhanced imaging prototype using full-thickness breast specimens.

RATIONALE AND OBJECTIVES: Conventional mammographic image contrast is derived from x-ray absorption, resulting in breast structure visualization due to density gradients that attenuate radiation without distinction between transmitted, scattered, or refracted x-rays. Diffraction-enhanced imaging (DEI) allows for increased contrast with decreased radiation dose compared to conventional mammographic imaging because of monochromatic x-rays, its unique refraction-based contrast mechanism, and excellent scatter rejection. However, a lingering drawback to the clinical translation of DEI has been the requirement for synchrotron radiation. MATERIALS AND METHODS: The authors' laboratory developed a DEI prototype (DEI-PR) using a readily available tungsten x-ray tube source and traditional DEI crystal optics, providing soft tissue images at 60 keV. Images of full-thickness human breast tissue specimens were acquired on synchrotron-based DEI (DEI-SR), DEI-PR, and digital mammographic systems. A panel of expert radiologists evaluated lesion feature visibility and correlation with pathology after receiving training on the interpretation of refraction contrast mammographic images. RESULTS: For mammographic features (mass, calcification), no significant differences were detected between the DEI-SR and DEI-PR systems. Benign lesions were perceived as better seen by radiologists using the DEI-SR system than the DEI-PR system at the [111] reflectivity, with generalizations limited by small sample size. No significant differences between DEI-SR and DEI-PR were detected for any other lesion type (atypical, cancer) at either crystal reflectivity. CONCLUSIONS: Thus, except for benign lesion characterizations, the DEI-PR system's performance was roughly equivalent to that of the traditional DEI system, demonstrating a significant step toward clinical translation of this modality for breast cancer applications.

Comparison of three methods to increase knowledge about breast cancer and breast cancer screening in screening mammography patients.

RATIONALE AND OBJECTIVES: The specific aim of the study was to determine which of several cost-effective interventions is best able to improve the breast cancer knowledge of women who present for screening mammography. MATERIALS AND METHODS: A total of 198 English-speaking women, with no personal or family history of breast cancer, were recruited and randomized to four groups when they presented to the clinic for a screening mammogram. All women filled in a demographic data form and answered a questionnaire containing nine questions about breast cancer, risk, and screening to assess their knowledge and perception. Three educational interventions were tested in this study. The first consisted of a brochure, which provided answers to the questionnaire items and addressed the issues in more depth. The second intervention was an educational conversation with a specially trained mammography technologist. She reviewed the subject's answers to the questionnaire items correcting and/or clarifying them. The third intervention consisted of the brochure together with the conversation with a trained technologist. There was also a control group that just filled in the study questionnaire but did not receive an educational intervention. The same questionnaire was administered by telephone 4 to 6 weeks after the screening experience to all study subjects. Changes in their knowledge and perceptions of breast cancer were measured and compared. RESULTS: A statistically significant increase in knowledge was found in all of the three investigated groups compared to the control group. There were no statistically significant differences in the amount of increase between women who underwent different interventions. CONCLUSIONS: All three interventions resulted in increased knowledge about breast cancer and screening. No differences in the amount of knowledge increase were found between three interventions tested. The educational brochure seems to represent the most convenient and least costly method to increase knowledge about breast cancer and screening among women who present for screening mammography.

Feasibility of breast preserving therapy with single fraction in situ radiotherapy delivered intraoperatively.

BACKGROUND: Accelerated partial breast irradiation (APBI) has gained widespread interest as a means of improving the convenience and availability of breast conserving radiotherapy. Intraoperative radiation therapy (IORT) is an APBI technique that delivers breast radiotherapy as a single dose at the time of partial mastectomy. We adapted the technique of Veronesi to deliver IORT prior to tumor excision to improve delivery to the region at risk and reduce the volume of normal tissue irradiated. METHODS: Patients age >or=55 with ultrasonographically defined tumors

Comparison of LCD and CRT displays based on efficacy for digital mammography.

RATIONALE AND OBJECTIVES: To compare two display technologies, cathode ray tube (CRT) and liquid crystal display (LCD), in terms of diagnostic accuracy for several common clinical tasks in digital mammography. MATERIALS AND METHODS: Simulated masses and microcalcifications were inserted into normal digital mammograms to produce an image set of 400 images. Images were viewed on one CRT and one LCD medical-quality display device by five experienced breast-imaging radiologists who rated the images using a categorical rating paradigm. The observer data were analyzed to determine overall classification accuracy, overall lesion detection accuracy, and accuracy for four specific diagnostic tasks: detection of benign masses, malignant masses, and microcalcifications, and discrimination of benign and malignant masses. RESULTS: Radiologists had similar overall classification accuracy (LCD: 0.83 +/- 0.01, CRT: 0.82 +/- 0.01) and lesion detection accuracy (LCD: 0.87 +/- 0.01, CRT: 0.85 +/- 0.01) on both displays. The difference in accuracy between LCD and CRT for the detection of benign masses, malignant masses, and microcalcifications, and discrimination of benign and malignant masses was -0.019 +/- 0.009, 0.020 +/- 0.008, 0.012 +/- 0.013, and 0.0094 +/- 0.011, respectively. Overall, the two displays did not exhibit any statistically significant difference (P > .05). CONCLUSION: This study explored the suitability of two different soft-copy displays for the viewing of mammographic images. It found that LCD and CRT displays offer similar clinical utility for mammographic tasks.

Correlation of HER-2/neu overexpression with mammography and age distribution in primary breast carcinomas.

RATIONALE AND OBJECTIVES: HER-2/neu is a valuable prognostic and therapeutic marker in primary breast carcinoma. The objective of this study was to determine the mammographic and patient characteristics (age) that correlate with HER-2/neu overexpression in primary breast carcinoma. MATERIALS AND METHODS: HER-2/neu characteristics and preoperative mammograms were available in 498 patients with 543 primary breast carcinomas (526 invasive carcinomas and 17 ductal carcinoma in situ). HER-2/neu status was determined by immunohistochemistry and fluorescence in situ hybridization. For evaluation of patient age distribution, age was divided into 5 groups. For mammography, breast composition and abnormal findings were categorized. Abnormal findings were divided into mass, calcification, architectural distortion, asymmetric density, or none. RESULTS: For age distribution, women under than 50 years had more frequent HER-2/neu overexpression than women aged 60-69 years (P < .05). On mammography, there was no significant correlation between breast composition and HER-2/neu status (P > .05). Calcifications were more significantly frequent in carcinomas with HER-2/neu overexpression (56%) than in those without HER-2/neu overexpression (40%) (P = .001). Of the 242 carcinomas with calcifications on mammography, fine linear morphology was more significantly frequent in carcinomas with HER-2/neu overexpression (20%) when compared with those without HER-2/neu overexpression (10%) (P = .023). Diffuse distribution of calcifications was more common in carcinomas with HER-2/neu overexpression (11%) compared with carcinomas without HER-2/neu overexpression (5%) (P = .051). CONCLUSION: HER-2/neu overexpression in primary breast carcinoma is correlated with patients' age (under age 50) and calcifications at mammography.

The positive predictive value for diagnosis of breast cancer full-field digital mammography versus film-screen mammography in the diagnostic mammographic population.

RATIONALE AND OBJECTIVES: Diagnostic mammography is performed on women with clinical symptoms that suggest breast cancer or women for whom further mammographic evaluation has been requested because of an abnormal screening mammography. We assessed whether the use of full-field digital mammography would improve the positive predictive value (PPV) for the diagnosis of breast cancer in a diagnostic population compared with film-screen mammography. MATERIALS AND METHODS: From January 2002 to December 2003, 11,621 patients underwent diagnostic mammography at the University of North Carolina Hospital, Chapel Hill. Among these 11,621 patients, 1400 lesions in 1121 patients underwent biopsy. We included the biopsy-performed lesions, so PPV3 was used for comparison of PPVs between film-screen mammography and full-field digital mammography. Six breast radiologists interpreted the images using the Breast Imaging Reporting and Data System of the American College of Radiology. PPV3s were compared between film-screen and full-field digital mammography in the entire study cohort and in specified subgroups according to different radiologists, breast density, and lesion type on mammography. The chi(2) and Fisher's exact tests were used for comparison of PPV3s between two modalities of mammography with the Bonferroni procedure for subgroup analysis. RESULTS: In the entire study cohort, PPV3s of full-field digital mammography and film-screen mammography were similar (difference in PPV3,-0.007; 95% confidence interval, -0.081 to 0.068; P = .8602). In predefined subgroups, there was no difference in PPV3 by the radiologist, breast density, or lesion type between two modalities of mammography (P > .005). CONCLUSION: There is no improvement in PPV for the diagnosis of breast cancer with full-field digital mammography compared with film-screen mammography in a large diagnostic population.

A comparative study of mobile electronic data entry systems for clinical trials data collection.

PURPOSE: To determine the speed, accuracy, ease of use, and user satisfaction of various electronic data entry platforms for use in the collection of mammography clinical trials data. METHOD AND MATERIALS: Four electronic data entry platforms were tested: standalone personal digital assistant (PDA), Tablet PC, digitizer Tablet/PDA Hybrid (DTP Hybrid), and digital pen (d-pen). Standard paper data entry was used as control. Each of five radiologist readers was assigned to enter interpretations for 20 screening mammograms using three out of the five data entry methods. Assistants recorded both start and stop data entry times of the radiologists and the number of help requests made. Data were checked for handwriting recognition accuracy for the d-pen platform using handwriting verification software. A user satisfaction survey was administered at the end of each platform reading session. RESULTS: Tablet PC and d-pen were statistically equivalent to conventional pen and paper in initial data entry speed. Average verification time for d-pen was significantly less than secondary electronic data entry of paper forms (p-value <0.001). The number of errors in handwriting recognition for d-pen was less than secondary electronic data entry of the paper forms data. Users were most satisfied with Tablet PC, d-pen, and conventional pen and paper for data entry. CONCLUSIONS: Tablet PC and d-pen are equally fast and easy-to-use data entry methods that are well tolerated by radiologist users. Handwriting recognition review and correction for the d-pen is significantly faster and more accurate than secondary manual keyboard and mouse data entry.

Comparison of full-field digital mammography to screen-film mammography with respect to contrast and spatial resolution in tissue equivalent breast phantoms.

To determine if the improved contrast resolution of full-field digital mammography (FFDM) with reduced spatial resolution allows for superior or equal phantom object detection compared with screen-film mammography (SFM). Tissue equivalent breast phantoms simulating an adipose to glandular ratio of 50/50,30/70, and 20/80 were imaged according to each manufacturers' recommendation with four full-field digital mammography units (Fuji, Sectra, Fischer, and General Electric) and a screen-film mammography unit (MammoMatII 2000, Siemens, Munich, Germany). A total of 20 images were obtained in both hard- and soft-copy formats. For the purpose of soft-copy display, the screen-film hard-copy images were digitized with a 50 microm micron scanner. Six radiologists, experts in breast imaging, and three physicists, experts in scoring mammography phantoms, participated in a reader study where each reader scored each phantom for visibility of line-pairs and for 24 objects (fibers, clusters of specks, and masses). The data were recorded, entered into a database, and analyzed by a mixed-effect model. The limiting spatial resolution in line-pairs per millimeter visible with the digital units was less, regardless of display modality used, than that provided by the screen-film unit. The difference was statistically significant for the General Electric (p < 0.01) and Fuji digital mammography units (p = 0.03). With respect to the number of visible objects, a statistically significant higher number could be detected with the screen-film unit as compared to the Fischer (p < 0.01) and Sectra (p < 0.01) digital mammography units, but there was no significant difference between the other digital units and screen film. Overall, there was significantly better performance on the 50/50 phantom than with the 30/70 and 20/80 phantoms (p = 0.01, p < 0.01) for object visibility. For the digital mammography units, soft-copy display performed better than hard-copy display for the Fischer and Sectra images, but worse for Fuji and General Electric. In addition, soft-copy display of digitized screen-film images was significantly better than hard-copy display (p =0.02) of the original screen films for object visibility, but worse for spatial resolution. The higher contrast resolution of the FFDM units tested did not result in improved detection of line-pair resolution or objects in the phantoms tested versus screen-film mammography. The phantom performance of a digital mammography unit seems to be influenced by the type of detection task (line-pair resolution versus object visibility), the display modality (soft-copy versus hard-copy) chosen to score the phantoms, and the parenchymal pattern composition of the phantom.

The effects of gray scale image processing on digital mammography interpretation performance.

RATIONALE AND OBJECTIVES: To determine the effects of three image-processing algorithms on diagnostic accuracy of digital mammography in comparison with conventional screen-film mammography. MATERIALS AND METHODS: A total of 201 cases consisting of nonprocessed soft copy versions of the digital mammograms acquired from GE, Fischer, and Trex digital mammography systems (1997-1999) and conventional screen-film mammograms of the same patients were interpreted by nine radiologists. The raw digital data were processed with each of three different image-processing algorithms creating three presentations-manufacturer's default (applied and laser printed to film by each of the manufacturers), MUSICA, and PLAHE-were presented in soft copy display. There were three radiologists per presentation. RESULTS: Area under the receiver operating characteristic curve for GE digital mass cases was worse than screen-film for all digital presentations. The area under the receiver operating characteristic for Trex digital mass cases was better, but only with images processed with the manufacturer's default algorithm. Sensitivity for GE digital mass cases was worse than screen film for all digital presentations. Specificity for Fischer digital calcifications cases was worse than screen film for images processed in default and PLAHE algorithms. Specificity for Trex digital calcifications cases was worse than screen film for images processed with MUSICA. CONCLUSION: Specific image-processing algorithms may be necessary for optimal presentation for interpretation based on machine and lesion type.

The role of magnetic resonance imaging in diagnosis and management of breast cancer.

A review of the literature on the current applications of breast magnetic resonance imaging (MRI) indications, their rationale and their place in diagnosis and management of breast cancer was given. Contrast-enhanced breast MRI is developing as a valuable adjunct to mammography and sonography. Its high sensitivity for invasive breast cancer establishes its superiority in evaluation of multifocality/multicentricity, tumor response to neoadjuvant chemotherapy, detection of recurrence, and staging. Emerging applications include spectroscopy, usage of new contrast agents, and MRI-guided interventions, including noninvasive treatment of breast cancer. Its potential benefit in screening high-risk women has yet to be established with prospective studies, particularly with regard to false positive results.