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Breast tomosynthesis, a three-dimensional x-ray based breast imaging technology, has been available for clinical use in the United States since 2011. In this paper we review the literature on breast cancer screening with this new technology including where gaps in knowledge remain. [ABSTRACT FROM AUTHOR]

Abstract: 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. [Copyright &y& Elsevier]

Abstract: This study investigated the feasibility of using low-dose multidetector dynamic computed tomography (CT) scan for imaging breast. We measured the radiation dose using a phantom at low- and standard-dose CT. To compare the image quality at low- and standard-dose CT, we evaluated normal breasts in 57 cases. In 44 cases with breast cancer, we assessed the staging and time-enhancement curves of breast cancer. In conclusion, the low-dose multidetector dynamic CT scan is feasible for the evaluation of the breast, with reduced radiation dose and with similar image quality when compared with standard-dose CT scan. In breast cancers, low-dose dynamic CT could be used for the staging of breast cancer before surgery. [Copyright &y& Elsevier]

This paper describes the American College of Radiology Imaging Network (ACRIN), a new National Cancer Institute cooperative group, formed to perform multicenter clinical trials in diagnostic imaging and imaging-guided therapeutic technologies.  The administrative structure of the organization and the mechanism by which trials are considered and approved for support are detailed.  The advantages of this funding mechanism over previous NCI efforts are discussed.  Detailed descriptions of the breast imaging protocols that ACRIN will open in the near future are provided.  The quality of radiology as an academic discipline is likely to improve due to the infrastructure and training provided by this new organization. [ABSTRACT FROM AUTHOR]

Discusses the advent of digital mammography in early breast cancer detection. Major limitations of film-screen mammography; Digital mammography detectors; Image processing algorithm; Digital mammography storage, retrieval and transmission.

Introduces the augmented-reality (AR) guidance technology for breast cyst aspiration to the medical community. Diagnostic purposes of ultrasound-guided biopsy of breast lesions; Requirements of an AR system; Outcome of phantom and patient studies.

Purpose: In the reconstruction of volume breast images from x‐ray projections in breast tomosynthesis, some tomographic systems truncate the image data presented to the radiologist such that a non‐negligible amount of tissue may be missing from the breast image. QC tests were conducted to determine if this problem existed in imaging in the TMIST study. Methods: Test tools developed for TMIST containing small objects at known heights were used in routine weekly and annual QC testing of tomosynthesis units to assess the degree to which phantom material that was irradiated in imaging was excluded from the reconstructed image. Results from 318 tests on five system types from three manufacturers are reported. Results: The presence and extent of this problem varied among system types. The cause was most frequently related to machine errors in the determination of breast thickness or to deflection of components during breast compression. In particular, the problem occurred when a compression paddle other than the one calibrated for tomosynthesis was used for the tests. This was also verified to have occurred in some clinical imaging. Conclusions: Missing volume can be avoided by intentionally reconstructing additional image slices above and below the presumed locations of the breast support and compression plate. A compression paddle which has been calibrated for tomosynthesis should be used both for clinical imaging and testing. The prevalence of this phenomenon suggests that more frequent testing for volume coverage may be advisable. [ABSTRACT FROM AUTHOR]

Background: The Tomosynthesis Mammography Imaging Screening Trial (TMIST), EA1151 conducted by the Eastern Cooperative Oncology Group (ECOG)/American College of Radiology Imaging Network (ACRIN) is a randomized clinical trial designed to assess the effectiveness for breast cancer screening of digital breast tomosynthesis (TM) compared to digital mammography (DM). Equipment from multiple vendors is being used in the study. Purpose: For the findings of the study to be valid and capture the true capacities of the two technology types, it is important that all equipment is operated within appropriate parameters with regard to image quality and dose. A harmonized QC program was established by a core physics team. Since there are over 120 trial sites, a centralized, automated QC program was chosen as the most practical design. This report presents results of the weekly QC testing program. A companion paper will review quality monitoring based on data from the headers of the patient images. Methods: Study images are collected centrally after de‐identification using the "TRIAD" application developed by ACR. The core physics team devised and implemented a minimal set of quality control (QC) tests to evaluate the tomosynthesis and 2D mammography systems. Weekly, monthly and annual testing is performed by the site mammography technologists with images submitted directly to the physics core. The weekly physics QC tests are described: SDNR of a low‐contrast mass object, artifact spread, spatial resolution, tracking of technical factors, and in‐slice noise power spectra. Results: As of December 31, 2022 (5 years), 145 sites with 411 machines had submitted QC data. A total of 136 742 TMIST participant screening imaging studies had been performed. The 5th and 95th percentile mean glandular doses for a single tomosynthesis exposure to a 4.0 cm thick PMMA phantom ("standard breast phantom") were 1.24 and 1.68 mGy respectively. The largest sources of QC non‐conformance were: operator error, not following the QC protocol exactly, unreported software updates and preventive maintenance activities that affected QC setpoints. Noise power spectra were measured, however, standardization of performance targets across machine types and software revisions was difficult. Nevertheless, for each machine type, test measurement results were very consistent when the protocol was followed. Deviations in test results were mostly related to software and hardware changes. Conclusion: Most systems performed very consistently. Although this is a harmonized program using identical phantoms and testing protocols, it is not appropriate to apply universal threshold or target metrics across the machine types because the systems have different non‐linear reconstruction algorithms and image display filters. It was found to be more useful to assess pass/fail criteria in terms of relative deviations from baseline values established when a system is first characterized and after equipment is changed. Generally, systems which needed repair failed suddenly, but in retrospect, for a few cases, drops in SDNR and increases in mAs were observed prior to tube failure. TMIST is registered as NCT03233191 by Clinicaltrials.gov [ABSTRACT FROM AUTHOR]

The authors discuss a study which compared the use of tomosynthesis and digital mammography in breast cancer screening. They provide an overview of the study, which found that the introduction of tomosynthesis provide significant decrease in recall rate. They note that tomosynthesis is more advance than digital mammography.

The article focuses on greater focus on conflict of interest brought about by the implementation of the Sunshine Act requirements. Topics discussed include the findings of a 2006 survey that 459 of the 688 responding departmental chairs acknowledged some form of personal relationship with the industry, the conflict brought about by an equity partnership between an academic health system and an outside corporation and the possible solution to address conflict of interest.

Discusses articles on the topic of breast imaging published in the March 1998 issue of the journal 'Breast Disease.' Articles devoted to the current state of the art in North America; Articles describing technologies that are not widely adopted as yet; Articles on technologies of uncertain future utility in breast imaging.

A response by Constantine Gatsonis, Etta D. Pisano and Edward Hendrick to several letters to the editor in response to their article "Diagnostic Performance of Digital Versus Film Mammography for Breast-Cancer Screening" in the October 27, 2005 issue is presented.

Background: Film mammography has limited sensitivity for the detection of breast cancer in women with radiographically dense breasts. We assessed whether the use of digital mammography would avoid some of these limitations. Methods: A total of 49,528 asymptomatic women presenting for screening mammography at 33 sites in the United States and Canada underwent both digital and film mammography. All relevant information was available for 42,760 of these women (86.3 percent). Mammograms were interpreted independently by two radiologists. Breast-cancer status was ascertained on the basis of a breast biopsy done within 15 months after study entry or a follow-up mammogram obtained at least 10 months after study entry. Receiver-operating-characteristic (ROC) analysis was used to evaluate the results. Results: In the entire population, the diagnostic accuracy of digital and film mammography was similar (difference between methods in the area under the ROC curve, 0.03; 95 percent confidence interval, –0.02 to 0.08; P=0.18). However, the accuracy of digital mammography was significantly higher than that of film mammography among women under the age of 50 years (difference in the area under the curve, 0.15; 95 percent confidence interval, 0.05 to 0.25; P=0.002), women with heterogeneously dense or extremely dense breasts on mammography (difference, 0.11; 95 percent confidence interval, 0.04 to 0.18; P=0.003), and premenopausal or perimenopausal women (difference, 0.15; 95 percent confidence interval, 0.05 to 0.24; P=0.002). Conclusions: The overall diagnostic accuracy of digital and film mammography as a means of screening for breast cancer is similar, but digital mammography is more accurate in women under the age of 50 years, women with radiographically dense breasts, and premenopausal or perimenopausal women. (ClinicalTrials.gov number, NCT00008346.) N Engl J Med 2005;353:1773-83. [ABSTRACT FROM AUTHOR]

Introduces articles in the June 2001 issue of the journal 'Breast Disease.' Focus on breast imaging; Strategies for improving patient knowledge, use and access to screening mammography; Ways in which radiologists and mammography technologists can best serve the needs of the public; Technical advances in the diagnosis and staging of breast cancer.

Purpose: Research biopsy specimens collected in clinical trials often present requirements beyond those of tumor biopsy specimens collected for diagnostic purposes. Research biopsies underpin hypothesis-driven drug development, pharmacodynamic assessment of molecularly targeted anticancer agents, and, increasingly, genomic assessment for precision medicine; insufficient biopsy specimen quality or quantity therefore compromises the scientific value of a study and the resources devoted to it, as well as each patient's contribution to and potential benefit from a clinical trial. Methods: To improve research biopsy specimen quality, we consulted with other translational oncology teams and reviewed current best practices. Results: Among the recommendations were improving communication between oncologists and interventional radiologists, providing feedback on specimen sufficiency, increasing academic recognition and financial support for the time investment required by radiologists to collect and preserve research biopsy specimens, and improving real-time assessment of tissue quality. Conclusion: Implementing these recommendations at the National Cancer Institute's Developmental Therapeutics Clinic has demonstrably improved the quality of biopsy specimens collected; more widespread dissemination of these recommendations beyond large clinical cancer centers is possible and will be of value to the community in improving clinical research and, ultimately, patient care. [ABSTRACT FROM AUTHOR]

Background: Estrogen plus progestin therapy increases both mammographic density and breast cancer incidence. Whether mammographic density change associated with estrogen plus progestin initiation predicts breast cancer risk is unknown.Methods: We conducted an ancillary nested case-control study within the Women's Health Initiative trial that randomly assigned postmenopausal women to daily conjugated equine estrogen 0.625 mg plus medroxyprogesterone acetate 2.5 mg or placebo. Mammographic density was assessed from mammograms taken prior to and one year after random assignment for 174 women who later developed breast cancer (cases) and 733 healthy women (controls). Logistic regression analyses included adjustment for confounders and baseline mammographic density when appropriate.Results: Among women in the estrogen plus progestin arm (97 cases/378 controls), each 1% positive change in percent mammographic density increased breast cancer risk 3% (odds ratio [OR] = 1.03, 95% confidence interval [CI] = 1.01 to 1.06). For women in the highest quintile of mammographic density change (>19.3% increase), breast cancer risk increased 3.6-fold (95% CI = 1.52 to 8.56). The effect of estrogen plus progestin use on breast cancer risk (OR = 1.28, 95% CI = 0.90 to 1.82) was eliminated in this study, after adjusting for change in mammographic density (OR = 1.00, 95% CI = 0.66 to 1.51).Conclusions: We found the one-year change in mammographic density after estrogen plus progestin initiation predicted subsequent increase in breast cancer risk. All of the increased risk from estrogen plus progestin use was mediated through mammographic density change. Doctors should evaluate changes in mammographic density with women who initiate estrogen plus progestin therapy and discuss the breast cancer risk implications. [ABSTRACT FROM AUTHOR]

Background: Mammography is not widely available in all countries, and breast cancer incidence is increasing. We considered performance characteristics using ultrasound (US) instead of mammography to screen for breast cancer.Methods: Two thousand eight hundred nine participants were enrolled at 20 sites in the United States, Canada, and Argentina in American College of Radiology Imaging 6666. Two thousand six hundred sixty-two participants completed three annual screens (7473 examinations) with US and film-screen (n = 4351) or digital (n = 3122) mammography and had biopsy or 12-month follow-up. Cancer detection, recall, and positive predictive values were determined. All statistical tests were two-sided.Results: One hundred ten women had 111 breast cancer events: 89 (80.2%) invasive cancers, median size 12 mm. The number of US screens to detect one cancer was 129 (95% bootstrap confidence interval [CI] = 110 to 156), and for mammography 127 (95% CI = 109 to 152). Cancer detection was comparable for each of US and mammography at 58 of 111 (52.3%) vs 59 of 111 (53.2%, P = .90), with US-detected cancers more likely invasive (53/58, 91.4%, median size 12 mm, range = 2-40 mm), vs mammography at 41 of 59 (69.5%, median size 13 mm, range = 1-55 mm, P < .001). Invasive cancers detected by US were more frequently node-negative, 34 of 53 (64.2%) vs 18 of 41 (43.9%) by mammography (P = .003). For 4814 incidence screens (years 2 and 3), US had higher recall and biopsy rates and lower PPV of biopsy (PPV3) than mammography: The recall rate was 10.7% (n = 515) vs 9.4% (n = 453, P = .03), the biopsy rate was 5.5% (n = 266) vs 2.0% (n = 97, P < .001), and PPV3 was 11.7% (31/266) vs 38.1% (37/97, P < .001).Conclusions: Cancer detection rate with US is comparable with mammography, with a greater proportion of invasive and node-negative cancers among US detections. False positives are more common with US screening. [ABSTRACT FROM AUTHOR]

Objectives: To assess radiologist confidence in the characterization of suspicious breast lesions with a dedicated three-dimensional breast computed tomography (DBCT) system in comparison to diagnostic two-dimensional digital mammography (dxDM). Materials and Methods: Twenty women were recruited who were to undergo a breast biopsy for a Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5 lesion evaluated with dxDM in this Institutional Review Board-approved study. The enrolled subjects underwent imaging of the breast(s) of concern using DBCT. Seven radiologists reviewed the cases. Each reader compared DBCT to the dxDM and was asked to specify the lesion type and BI-RADS score for each lesion and modality. They also compared lesion characteristics: Shape for masses or morphology for calcifications; and margins for masses or distribution for calcifications between the modalities using confidence scores (0-100). Results: Twenty-four biopsied lesions were included in this study: 17 (70.8%) masses and 7 (29.2%) calcifications. Eight (33.3%) lesions were malignant, and 16 (66.7%) were benign. Across all lesions, there was no significant difference in the margin/distribution (Δ = -0.99, P = 0.84) and shape/ morphology (Δ = -0.10, P = 0.98) visualization confidence scores of DBCT in relation to dxDM. However, analysis by lesion type showed a statistically significant increase in reader shape (Δ =11.34, P = 0.013) and margin (Δ =9.93, P = 0.023) visualization confidence with DBCT versus dxDM for masses and significant decrease in reader morphology (Δ = - 29.95, P = 0.001) and distribution (Δ = - 28.62, P = 0.002) visualization confidence for calcifications. Conclusion: Reader confidence in the characterization of suspicious masses is significantly improved with DBCT, but reduced for calcifications. Further study is needed to determine whether this technology can be used for breast cancer screening. [ABSTRACT FROM AUTHOR]

As a potential biomarker for women's cardiovascular and chronic kidney diseases, breast arterial calcification (BAC) in mammography has become an emerging research topic in recent years. To provide more objective measurement for vascular structures with calcium depositions in mammography, a new computerized method is introduced in this paper to delineate the calcified vessels. Specifically, we leverage two underlying cues, namely calcification and vesselness, into a multiple seeded tracking with uncertainty scheme. This new vessel-tracking scheme generates plenty of sampling paths to describe the complicated topology of the vascular structures with calcium depositions. A compiling and linking process is further carried out to organize the sampling paths together to be the vessel segments that likely belong to the same vessel tract. The proposed method has been evaluated on 63 mammograms, by comparison with manual delineations from two experts using various assessment metrics. The experiment results confirm the efficacy and stability of the proposed method, and also indicate that the proposed method can be potentially used as a convenient BAC measurement tool in replacement of the trivial and tedious manual delineation tasks. [ABSTRACT FROM AUTHOR]

Background: Although breast cancer screening with mammography and magnetic resonance imaging (MRI) is recommended for breast cancer-susceptibility gene (BRCA) mutation carriers, there is no current consensus on the optimal screening regimen.Methods: The authors used a computer simulation model to compare 6 annual screening strategies (film mammography [FM], digital mammography [DM], FM and magnetic resonance imaging [MRI] or DM and MRI contemporaneously, and alternating FM/MRI or DM/MRI at 6-month intervals) beginning at ages 25 years, 30 years, 35 years, and 40 years, and 2 strategies of annual MRI with delayed alternating DM/FM versus clinical surveillance alone. Strategies were evaluated without and with mammography-induced breast cancer risk using 2 models of excess relative risk. Input parameters were obtained from the medical literature, publicly available databases, and calibration.Results: Without radiation risk effects, alternating DM/MRI starting at age 25 years provided the highest life expectancy (BRCA1, 72.52 years, BRCA2, 77.63 years). When radiation risk was included, a small proportion of diagnosed cancers was attributable to radiation exposure (BRCA1, <2%; BRCA2, <4%). With radiation risk, alternating DM/MRI at age 25 years or annual MRI at age 25 years/delayed alternating DM at age 30 years was the most effective, depending on the radiation risk model used. Alternating DM/MRI starting at age 25 years also produced the highest number of false-positive screens per woman (BRCA1, 4.5 BRCA2, 8.1).Conclusions: Annual MRI at age 25 years/delayed alternating DM at age 30 years is probably the most effective screening strategy in BRCA mutation carriers. Screening benefits, associated risks, and personal acceptance of false-positive results should be considered in choosing the optimal screening strategy for individual women. [ABSTRACT FROM AUTHOR]

BACKGROUND: Although breast cancer screening with mammography and magnetic resonance imaging (MRI) is recommended for breast cancer-susceptibility gene (BRCA) mutation carriers, there is no current consensus on the optimal screening regimen. METHODS: The authors used a computer simulation model to compare 6 annual screening strategies (film mammography [FM], digital mammography [DM], FM and magnetic resonance imaging [MRI] or DM and MRI contemporaneously, and alternating FM/MRI or DM/MRI at 6-month intervals) beginning at ages 25 years, 30 years, 35 years, and 40 years, and 2 strategies of annual MRI with delayed alternating DM/FM versus clinical surveillance alone. Strategies were evaluated without and with mammography-induced breast cancer risk using 2 models of excess relative risk. Input parameters were obtained from the medical literature, publicly available databases, and calibration. RESULTS: Without radiation risk effects, alternating DM/MRI starting at age 25 years provided the highest life expectancy ( BRCA1, 72.52 years, BRCA2, 77.63 years). When radiation risk was included, a small proportion of diagnosed cancers was attributable to radiation exposure ( BRCA1, <2%; BRCA2, <4%). With radiation risk, alternating DM/MRI at age 25 years or annual MRI at age 25 years/delayed alternating DM at age 30 years was the most effective, depending on the radiation risk model used. Alternating DM/MRI starting at age 25 years also produced the highest number of false-positive screens per woman ( BRCA1, 4.5 BRCA2, 8.1). CONCLUSIONS: Annual MRI at age 25 years/delayed alternating DM at age 30 years is probably the most effective screening strategy in BRCA mutation carriers. Screening benefits, associated risks, and personal acceptance of false-positive results should be considered in choosing the optimal screening strategy for individual women. Cancer 2012. © 2011 American Cancer Society. [ABSTRACT FROM AUTHOR]

The article discusses a substudy undertaken to assess the rate and stage of cancers detected with a single screening magnetic resonance imaging (MRI). Participants to the study included women who were asymptomatic and presented for routine annual mammography with heterogeneously dense or extremely dense breast tissue with at least one other risk factor for breast cancer. It suggests that the addition of screening MRI rather than ultrasound to mammography in a population of women at intermediate risk with dense breast may not be proper specially when the current high false-positive rates, cost and reduced tolerability of MRI are considered.

Background: To compare the diagnostic accuracy of two continuous screening tests, a common approach is to test the difference between the areas under the receiver operating characteristic (ROC) curves. After study participants are screened with both screening tests, the disease status is determined as accurately as possible, either by an invasive, sensitive and specific secondary test, or by a less invasive, but less sensitive approach. For most participants, disease status is approximated through the less sensitive approach. The invasive test must be limited to the fraction of the participants whose results on either or both screening tests exceed a threshold of suspicion, or who develop signs and symptoms of the disease after the initial screening tests. The limitations of this study design lead to a bias in the ROC curves we call paired screening trial bias. This bias reflects the synergistic effects of inappropriate reference standard bias, differential verification bias, and partial verification bias. The absence of a gold reference standard leads to inappropriate reference standard bias. When different reference standards are used to ascertain disease status, it creates differential verification bias. When only suspicious screening test scores trigger a sensitive and specific secondary test, the result is a form of partial verification bias. Methods: For paired screening tests with bivariate normally distributed scores, we give formulae and programs to quantify the effect of paired screening trial bias on a paired comparison of area under the curves. We fix the prevalence of disease, and the chance a diseased subject manifests signs and symptoms. We derive the formulas for true sensitivity and specificity, and those for the sensitivity and specificity observed by the study investigator. Results: The observed area under the ROC curves is quite different from the true area under the ROC curves. The typical direction of the bias is a strong inflation in sensitivity, paired with a concomitant slight deflation of specificity. Conclusion: In paired trials of screening tests, when area under the ROC curve is used as the metric, bias may lead researchers to make the wrong decision as to which screening test is better. [ABSTRACT FROM AUTHOR]

The article presents a study comparing the diagnostic efficacy of screening with ultrasound plus mammography versus mammography alone in women with an increased risk of developing breast cancer. The design, setting and participants of the study which involved 2,809 women are detailed. The outcomes of both screening methods were measured for diagnostic yield, sensitivity, specificity, and diagnostic accuracy. Researchers concluded that adding ultrasound screening to mammography will significantly increase the number of breast cancers diagnosed among high-risk women, but it will also raise the number of false positives.

Background: The DMIST (Digital Mammography Imaging Screening Trial) reported improved breast cancer detection with digital mammography compared with film mammography in selected population subgroups, but it did not assess the economic value of digital relative to film mammography screening.Objective: To evaluate the cost-effectiveness of digital mammography screening for breast cancer.Design: Validated, discrete-event simulation model.Data Sources: Data from DMIST and publicly available U.S. data.Target Population: U.S. women age 40 years or older.Time Horizon: Lifetime.Perspective: Societal and Medicare.Intervention: All-film mammography screening; all-digital mammography screening; and targeted digital mammography screening, which is age-targeted digital mammography (for women <50 years of age) and age- and density-targeted digital mammography (for women <50 years of age or women > or =50 years of age with dense breasts).Outcome Measures: Cost per quality-adjusted life-year (QALY) gained.Results Of Base-case Analysis: All-digital mammography screening cost $331,000 (95% CI, $268,000 to $403,000) per QALY gained relative to all-film mammography screening but was more costly and less effective than targeted digital mammography screening. Targeted digital mammography screening resulted in more screen-detected cases of cancer and fewer deaths from cancer than either all-film or all-digital mammography screening, with cost-effectiveness estimates ranging from $26,500 (CI, $21,000 to $33,000) per QALY gained for age-targeted digital mammography to $84,500 (CI, $75,000 to $93,000) per QALY gained for age- and density-targeted digital mammography. In the Medicare population, the cost-effectiveness of density-targeted digital mammography screening varied from a base-case estimate of $97,000 (CI, $77,000 to $131,000) to $257,000 per QALY gained (CI, $91,000 to $536,000) in the alternative-case analyses, in which the sensitivity of film mammography was increased and the sensitivity of digital mammography in women with nondense breasts was decreased.Results Of Sensitivity Analysis: Results were sensitive to the cost of digital mammography and to the prevalence of dense breasts.Limitations: Results were dependent on model assumptions and DMIST findings.Conclusion: Relative to film mammography, screening for breast cancer by using all-digital mammography is not cost-effective. Age-targeted screening with digital mammography seems cost-effective, whereas density-targeted screening strategies are more costly and of uncertain value, particularly among women age 65 years or older. [ABSTRACT FROM AUTHOR]

Background: The DMIST (Digital Mammography Imaging Screening Trial) reported improved breast cancer detection with digital mammography compared with film mammography in selected population subgroups, but it did not assess the economic value of digital relative to film mammography screening. Objective: To evaluate the cost-effectiveness of digital mammography screening for breast cancer. Design: Validated, discrete-event simulation model. Data Sources: Data from DMIST and publicly available U.S. data. Target Population: U.S. women age 40 years or older. Time Horizon: Lifetime. Perspective: Societal and Medicare. Intervention: All-film mammography screening; all-digital mammography screening; and targeted digital mammography screening, which is age-targeted digital mammography (for women <50 years of age) and age- and density-targeted digital mammography (for women <50 years of age or women ≥50 years of age with dense breasts). Outcome Measures: Cost per quality-adjusted life-year (QALY) gained. Results of Base-Case Analysis: All-digital mammography screening cost $331 000 (95% CI, $268 000 to $403 000) per QALY gained relative to all-film mammography screening but was more costly and less effective than targeted digital mammography screening. Targeted digital mammography screening resulted in more screen-detected cases of cancer and fewer deaths from cancer than either all-film or all-digital mammography screening, with cost-effectiveness estimates ranging from $26 500 (CI, $21 000 to $33 000) per QALY gained for age-targeted digital mammography to $84 500 (CI, $75 000 to $93 000) per QALY gained for age- and density-targeted digital mammography. In the Medicare population, the cost-effectiveness of density-targeted digital mammography screening varied from a base-case estimate of $97 000 (CI, $77 000 to $131 000) to $257 000 per QALY gained (CI, $91 000 to $536 000) in the alternative-case analyses, in which the sensitivity of film mammography was increased and the sensitivity of digital mammography in women with nondense breasts was decreased. Results of Sensitivity Analysis: Results were sensitive to the cost of digital mammography and to the prevalence of dense breasts. Limitations: Results were dependent on model assumptions and DMIST findings. Conclusion: Relative to film mammography, screening for breast cancer by using all-digital mammography is not cost-effective. Age-targeted screening with digital mammography seems cost-effective, whereas density-targeted screening strategies are more costly and of uncertain value, particularly among women age 65 years or older. [ABSTRACT FROM AUTHOR]

Background: Even after careful clinical and mammographic evaluation, cancer is found in the contralateral breast in up to 10% of women who have received treatment for unilateral breast cancer. We conducted a study to determine whether magnetic resonance imaging (MRI) could improve on clinical breast examination and mammography in detecting contralateral breast cancer soon after the initial diagnosis of unilateral breast cancer. Methods: A total of 969 women with a recent diagnosis of unilateral breast cancer and no abnormalities on mammographic and clinical examination of the contralateral breast underwent breast MRI. The diagnosis of MRI-detected cancer was confirmed by means of biopsy within 12 months after study entry. The absence of breast cancer was determined by means of biopsy, the absence of positive findings on repeat imaging and clinical examination, or both at 1 year of follow-up. Results: MRI detected clinically and mammographically occult breast cancer in the contralateral breast in 30 of 969 women who were enrolled in the study (3.1%). The sensitivity of MRI in the contralateral breast was 91%, and the specificity was 88%. The negative predictive value of MRI was 99%. A biopsy was performed on the basis of a positive MRI finding in 121 of the 969 women (12.5%), 30 of whom had specimens that were positive for cancer (24.8%); 18 of the 30 specimens were positive for invasive cancer. The mean diameter of the invasive tumors detected was 10.9 mm. The additional number of cancers detected was not influenced by breast density, menopausal status, or the histologic features of the primary tumor. Conclusions: MRI can detect cancer in the contralateral breast that is missed by mammography and clinical examination at the time of the initial breast-cancer diagnosis. (ClinicalTrials.gov number, NCT00058058 [ClinicalTrials.gov].). [ABSTRACT FROM AUTHOR]

Background Even after careful clinical and mammographic evaluation, cancer is found in the contralateral breast in up to 10% of women who have received treatment for unilateral breast cancer. We conducted a study to determine whether magnetic resonance imaging (MRI) could improve on clinical breast examination and mammography in detecting contralateral breast cancer soon after the initial diagnosis of unilateral breast cancer. Methods A total of 969 women with a recent diagnosis of unilateral breast cancer and no abnormalities on mammographic and clinical examination of the contralateral breast underwent breast MRI. The diagnosis of MRI-detected cancer was confirmed by means of biopsy within 12 months after study entry. The absence of breast cancer was determined by means of biopsy, the absence of positive findings on repeat imaging and clinical examination, or both at 1 year of follow-up. Results MRI detected clinically and mammographically occult breast cancer in the contralateral breast in 30 of 969 women who were enrolled in the study (3.1%). The sensitivity of MRI in the contralateral breast was 91%, and the specificity was 88%. The negative predictive value of MRI was 99%. A biopsy was performed on the basis of a positive MRI finding in 121 of the 969 women (12.5%), 30 of whom had specimens that were positive for cancer (24.8%); 18 of the 30 specimens were positive for invasive cancer. The mean diameter of the invasive tumors detected was 10.9 mm. The additional number of cancers detected was not influenced by breast density, menopausal status, or the histologic features of the primary tumor. Conclusions MRI can detect cancer in the contralateral breast that is missed by mammography and clinical examination at the time of the initial breast-cancer diagnosis. (ClinicalTrials.gov number, NCT00058058.) [ABSTRACT FROM AUTHOR]

Background: Film mammography has limited sensitivity for the detection of breast cancer in women with radiographically dense breasts. We assessed whether the use of digital mammography would avoid some of these limitations. Methods: A total of 49,528 asymptomatic women presenting for screening mammography at 33 sites in the United States and Canada underwent both digital and film mammography. All relevant information was available for 42,760 of these women (86.3 percent). Mammograms were interpreted independently by two radiologists. Breast-cancer status was ascertained on the basis of a breast biopsy done within 15 months after study entry or a follow-up mammogram obtained at least 10 months after study entry. Receiver-operating-characteristic (ROC) analysis was used to evaluate the results. Results: In the entire population, the diagnostic accuracy of digital and film mammography was similar (difference between methods in the area under the ROC curve, 0.03; 95 percent confidence interval, -0.02 to 0.08; P=0.18). However, the accuracy of digital mammography was significantly higher than that of film mammography among women under the age of 50 years (difference in the area under the curve, 0.15; 95 percent confidence interval, 0.05 to 0.25; P=0.002), women with heterogeneously dense or extremely dense breasts on mammography (difference, 0.11; 95 percent confidence interval, 0.04 to 0.18; P=0.003), and premenopausal or perimenopausal women (difference, 0.15; 95 percent confidence interval, 0.05 to 0.24; P=0.002). Conclusions: The overall diagnostic accuracy of digital and film mammography as a means of screening for breast cancer is similar, but digital mammography is more accurate in women under the age of 50 years, women with radiographically dense breasts, and premenopausal or perimenopausal women. (ClinicalTrials.gov number, NCT00008346.) [ABSTRACT FROM AUTHOR]

Background: Increased mammographic density reduces the sensitivity of screening mammography, is associated with increased breast cancer risk, and may be hormone related. We assessed the effect of estrogen-plus-progestin therapy on mammographic density. Methods: In a racially and ethnically diverse ancillary study of the Women's Health Initiative, we examined data from 413 postmenopausal women who had been randomly assigned to receive daily combined conjugated equine estrogens (0.625 mg) plus medroxyprogesterone acetate (i.e., progestin; 2.5 mg) (n = 202) or daily placebo (n = 211). We assessed the effect of estrogen plus progestin on measured mammographic percent density and abnormal findings over a 1-year and 2-year period. All tests of statistical significance were two-sided and were based on F tests or t tests from mixed-effects models. Results: Mean mammographic percent density increased by 6.0% at year 1, compared with baseline, in the estrogen-plus-progestin group but decreased by 0.9% in the placebo group (difference = 6.9%, 95% confidence interval [CI] = 5.3% to 8.5%; P<.001). The mean changes in mammographic density persisted but were attenuated slightly after 2 years, with an absolute increase of 4.9% in the estrogen-plus-progestin group and a decrease of 0.8% in the placebo group (difference = 5.7%, 95% CI = 4.3% to 7.3%; P«.001). These effects were consistent across racial/ethnic groups but were higher among women aged 70–79 years in the estrogen-plus-progestin group (mean increase at year 1 = 11.6%) than in the placebo group (mean decrease at year 1 = 0.1%) (difference of the means = 11.7%, 95% CI = 8.2% to 15.4%; P«.001, comparing across age groups). At year 1, women who were adherent to treatment in the estrogen-plus-progestin group had a mean increase in density of 7.7% (95% CI = 5.9% to 9.5%), and women in the placebo group had a mean decrease in density of 1.1% (95% CI = 0.3% to 1.9%). Use of estrogen plus progestin was associated with an increased risk of having an abnormal mammogram at year 1 (relative risk = 3.9, 95% CI = 1.5 to 10.2; P = .003), compared with placebo, that was not explained by an increase in density. Conclusions: Use of up 10 2 years of estrogen plus progestin was associated with increases in mammographic density. [ABSTRACT FROM AUTHOR]

Objective: To compare image quality and diagnostic accuracy of 2D with 3D ultrasonography in solid breast masses. Methods and Material: To rate image quality, two radiologists compared lesion contrast and characterization of 507 solid breast masses in 2D and 3D ultrasonography and then graded the 3D imaging in 3-point scale. To characterize the masses, the same radiologists rated the examination for clarity of margin, posterior acoustic feature, and clustered microcalcifications within a mass. In addition, the masses were assigned BI-RADS categories as proposed by the American College of Radiology, criteria using just ultrasonographic features. In the 202 pathologically confirmed cases, sensitivity, specificity, positive predictive value, negative predictive value, and false negative rate for diagnosis of breast cancer in 2D and 3D ultrasonography were assessed. Image quality and diagnostic accuracy were further evaluated according to the size of the masses. Results: Two observers rated 3D imaging superior to 2D imaging in terms of lesion contrast and characterization of the masses. Especially, superiority of 3D ultrasonography in terms of image quality was increasing in more than 10 mm sized masses. However, diagnostic accuracy including sensitivity, specificity, positive predictive value, negative predictive value, and false negative rate for diagnosis of breast cancer of 3D imaging was not different from 2D imaging. Conclusion: In spite of superior image quality on 3D ultrasonography, it does not provide additional benefits to diagnostic accuracy for diagnosis of breast cancer. [ABSTRACT FROM AUTHOR]

Context Breast magnetic resonance imaging (MRI) has been shown to have high sensitivity for cancer detection and is increasingly used following mammography to evaluate suspicious breast lesions. Objective To determine the accuracy of breast MRI in conjunction with mammography for the detection of breast cancer in patients with suspicious mammographic or clinical findings. Design, Setting, and Patients Prospective multicenter investigation of the International Breast MR Consortium conducted at 14 university hospitals in North America and Europe from June 2, 1998, through October 31, 2001, of 821 patients referred for breast biopsy for American College of Radiology category 4 or 5 mammographic assessment or suspicious clinical or ultrasound finding. Interventions MRI examinations performed prior to breast biopsy; MRI results were interpreted at each site, which were blinded to pathological results. Main Outcome Measures Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of breast MRI. Results Among the 821 patients, there were 404 malignant index lesions, of which 63 were ductal carcinoma in situ (DCIS) and 341 were invasive carcinoma. Of the 417 nonmalignant index lesions, 366 were benign, 47 showed atypical histology, and 4 were lobular carcinoma in situ. The AUC pooled over all institutions was 0.88 (95% confidence interval [CI], 0.86-0.91). MRI correctly detected cancer in 356 of 404 cancer cases (DCIS or invasive cancer), resulting in a sensitivity of 88.1% (95% CI, 84.6%-91.1%), and correctly identified as negative for cancer 281 of 417 cases without cancer, resulting in a specificity of 67.7% (95% CI, 62.7%-71.9%). MRI performance was not significantly affected by mammographic breast density, tumor histology, or menopausal status. The positive predictive values for 356 of 492 patients was 72.4% (95% CI, 68.2%-76.3%) and of mammography for 367 of 695 patients was 52.8% (95% CI, 49.0%-56.6%) (P<.005). Dynamic MRI did not... [ABSTRACT FROM AUTHOR]

We report the results of a randomized, controlled trial to compare the accuracy of standard ultrasound-guided needle biopsy to biopsies performed using a 3D Augmented Reality (AR) guidance system. A board-certified radiologist conducted 50 core biopsies of breast phantoms, with biopsies randomly assigned to one of the methods in blocks of five biopsies each. The raw ultrasound data from each biopsy was recorded. Another board-certified radiologist, blinded to the actual biopsy guidance mechanism, evaluated the ultrasound recordings and determined the distance of the biopsy from the ideal position. A repeated measures analysis of variance indicated that the head-mounted display method led to a statistically significantly smaller mean deviation from the desired target than did the standard display method (2.48 mm for control versus 1.62 mm for augmented reality, p<0.02). This result suggests that AR systems can offer improved accuracy over traditional biopsy guidance methods. [Copyright &y& Elsevier]