Supplemental Screening In Women Research Articles

SuppClinical guidelines for the management of mammographic density: A systematic review of breast screening guidelines worldwide.

High breast density is an independent risk factor for breast cancer and decreases the sensitivity of mammography. This systematic review synthesizes the international clinical guidelines and the evidence base for screening and supplemental screening recommendations in women with dense breasts. A systematic search of CINHAL, Embase and Medline databases was performed in August 2023 and grey literature searched in January 2024. Two authors independently assessed study eligibility and quality (Appraisal of Guidelines for Research and Evaluation II instrument). Of 3,809 articles, 23 guidelines published from 2014 to 2024 were included. The content and quality varied between the guidelines; the average AGREE II total score was 58% (range, 23% to 87%). Most guidelines recommended annual or biennial screening mammography for women over 40 years with dense breasts (n = 16). Other guidelines recommended breast tomosynthesis (DBT, n = 6) or magnetic resonance imaging (MRI, n = 1) as the preferred screening modality. A third of the guidelines (n = 8) did not recommend supplemental screening for women with dense breasts. Of those which recommended supplemental screening (n = 14), ultrasound was the preferred modality (n = 7), with MRI (n = 3), DBT (n = 3) and contrast-enhanced mammography (n = 2) also recommended. Consensus on supplemental screening in women with dense breasts is lacking. The quality of the guidelines is variable, and recommendations are largely based on low-quality evidence. As evidence of the benefits versus harms of supplemental screening in women with dense breasts is evolving, it is imperative to improve the methodological quality of breast cancer screening and supplemental screening guidelines.

Abstract PO2-28-10: Analysis of whole breast ultrasound image sequence reading time with a new FDA approved automated whole breast ultrasound tomography system for supplemental screening in women with dense breasts

Abstract Purpose: Ultrasound technology as a supplement to mammography for screening women with dense breasts increases cancer detection. However, automated whole breast ultrasound technologies have been shown to substantially increase radiologist reading time. We conducted a reading validation program to assess how quickly and accurately radiologists could interpret images from a new automated whole breast ultrasound prior to launching a prospective case collection registry. Methods: The study analyzed 500 reading times of bilateral screening breast ultrasounds obtained from SoftVue Automated Whole Breast Ultrasound (SV) (Delphinus Medical) in women with dense breasts. For this proctored reading validation program, 20 bilateral screening ultrasound cases were selected. Thecases included a mix of normal, cysts, benign masses, cancers, and implants. 25 MSQA-trained radiologists with varying experience from 9 institutions across the United States each read the 20 cases. The same hanging protocol was used, beginning with sequences of Wafer and Sound Speed to identify an area of interest, Reflection to determine if the area persists, and then Stiffness Fusion for further confirmation and characterization. The primary outcome was reading time per bilateral ultrasound. Reading times were compared using linear mixed effects models for findings in neither, one, or both breasts and for subgroups of cancer and benign findings. Mean reading time was 3.3± 1.76 minutes (n=498, median 2.9min) per case. Cases that were negative in both breasts tended to have faster read times (2.7min, sd=1.32) compared to those with findings in one breast (3.2min, sd=1.57) or findings in both breasts (3.8min, sd=2.14). Mean read times for cases with clinical findings were within a minute of the mean time for normal cases across all case types. Conclusion Breast image sequences of Wafer, Sound Speed, Reflection, and Stiffness Fusion from SV ultrasound tomography facilitate bilateral ultrasound mean reading times of less than 4 minutes per case. Clinical Significance: SV, used as an adjunct to mammography in screening women with dense breasts, offers the benefits of increased cancer detection with supplemental ultrasound with little increase in radiologist reading time. Table 1: Analysis of Bilateral SV Read Time Across Types of Case Clinical Findings Citation Format: Mary Yamashita, Taylor Mahoney, Patrick Walker, Linda Hovanessian Larsen. Analysis of whole breast ultrasound image sequence reading time with a new FDA approved automated whole breast ultrasound tomography system for supplemental screening in women with dense breasts [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-28-10.

Contrast-enhanced breast imaging: Current status and future challenges

BackgroundContrast-enhanced breast MRI and recently also contrast-enhanced mammography (CEM) are available for breast imaging. The aim of the current overview is to explore existing evidence and ongoing challenges of contrast-enhanced breast imaging. MethodsThis narrative provides an introduction to the contrast-enhanced breast imaging modalities breast MRI and CEM. Underlying principle, techniques and BI-RADS reporting of both techniques are described and compared, and the following indications and ongoing challenges are discussed: problem-solving, high-risk screening, supplemental screening in women with extremely dense breast tissue, breast implants, neoadjuvant systemic therapy (NST) response monitoring, MRI-guided and CEM- guided biopsy. ResultsTechnique and reporting for breast MRI are standardised, for the newer CEM standardisation is in progress. Similarly, compared to other modalities, breast MRI is well established as superior for problem-solving, screening women at high risk, screening women with extremely dense breast tissue or with implants; and for monitoring response to NST. Furthermore, MRI-guided biopsy is a reliable technique with low long-term false negative rates. For CEM, data is as yet either absent or limited, but existing results in these settings are promising. ConclusionContrast-enhanced breast imaging achieves highest diagnostic performance and should be considered essential. Of the two contrast-enhanced modalities, evidence of breast MRI superiority is ample, and preliminary results on CEM are promising, yet CEM warrants further study.

Screening Breast MRI and Gadolinium Deposition: Cause for Concern?

Gadolinium-based contrast agents (GBCAs) have been used worldwide for over 30 years and have enabled lifesaving diagnoses. Contrast-enhanced breast MRI is frequently used as supplemental screening for women with an elevated lifetime risk of breast cancer. Data have emerged that indicate a fractional amount of administered gadolinium is retained in the bone, skin, solid organs, and brain tissues of patients with normal renal function, although there are currently no reliable data regarding the clinical or biological significance of this retention. Linear GBCAs are associated with a higher risk of gadolinium retention than macrocyclic agents. Over the course of their lives, screened women may receive high cumulative doses of GBCA. Therefore, as breast MRI screening utilization increases, thoughtful use of GBCA is indicated in this patient population.

BI-RADS 3 on Screening Breast Ultrasound: What Is It and What Is the Appropriate Management?

US is widely used in breast imaging for diagnostic purposes and is also used increasingly for supplemental screening in women with dense breasts. US frequently depicts masses that are occult on mammography, even after tomosynthesis, and the vast majority of such masses are benign. Many masses seen only on screening US are easily recognized as benign simple cysts. Probably benign, BI-RADS 3, or low suspicion, BI-RADS 4A masses are also common and often prompt short-interval follow-up or biopsy, respectively, yet the vast majority of these are benign. This review details appropriate characterization, classification, and new approaches to the management of probably benign masses seen on screening US that can reduce false positives and, thereby, reduce costs and patient anxiety.

Availability Versus Utilization of Supplemental Breast Cancer Screening Post Passage of Breast Density Legislation.

Objective: Despite the lack of evidence that supplemental screening in women with dense breasts reduces breast cancer mortality, 38 states have passed breast density legislation, with some including recommendations for supplemental screening. The objective of this study is to compare the availability versus use of supplemental breast cancer screening modalities and determine factors driving use of supplemental screening in rural versus urban settings. Methods: A 50-item mailed survey using the Tailored Design Method was sent to American College of Radiology mammography-accredited facilities in North Carolina in 2017. Respondents included 94 facilities (48 rural and 46 urban locations). Survey questions focused on breast cancer and supplemental screening services, breast density, risk factors/assessment, and facility demographics. Results: The survey response rate was 60.3% (94/156). Among the 94 respondents, 64.0% (n = 60) reported availability of any type of supplemental screening (digital breast tomosynthesis [DBT], ultrasound, or magnetic resonance imaging [MRI]). In facilities where supplemental screening modalities were available, the most commonly utilized supplemental screening modality was DBT (96.4%), compared with ultrasound (35.7%) and MRI (46.7%). Facilities reported using supplemental screening based on patient breast density (48.3%), referring physician recommendation (63.3%), reading radiologist recommendation (63.3%), breast cancer risk factors (48.3%), and patient request (40.0%). Urban facilities were more likely than rural facilities to base supplemental screening on breast cancer risk factors (62.5% vs. 32.1%; p-value = 0.019), referring physician (75.0% vs. 50.0%; p-value = 0.045), and reading radiologist (78.1% vs. 46.4%; p-value = 0.011). Conclusion: In our study, supplemental screening modalities were widely available, with facilities more likely to use DBT for supplemental screening compared to other modalities.

Trends of Supplemental Screening in Women With Dense Breasts

The objective of this study was to survey current trends in supplemental screening across various practice types and to understand factors that affect these practice patterns. In this institutional review board-exempt study, a 12-question survey was sent out to ACR lead interpreting physicians. The survey inquired about practice features and the utilization of supplemental screening. A total of 902 of 4,688 lead interpreting breast imaging physicians (19.2%) responded to our survey. Of those respondents, 617 respondents (68.4%) worked in practices that offered supplemental breast cancer screening. Screening ultrasound was the most commonly utilized supplemental screening modality (53%). There was variability in methods of referral for supplemental screening, with referral through the ordering provider (56%) being the most common. Academic practices, private practices with breast specialization, and practices in the Northeast were more likely to provide supplemental screening (P < .05). There were significant relationships between the presence of state density notification legislation, the number of breast imaging trained radiologists, and the volume of mammographic studies performed per day and the availability of supplemental screening (P < .05). The use of automated breast density assessment software and patient education brochures about density and supplemental screening also had significant relationships with the availability of supplemental screening (P < .05). The majority of practices surveyed are utilizing supplemental screening, but there is significant variability in the modalities used and the methods of referral. There are practice features that correlate with the availability of supplemental screening, and understanding these features provides further insight into current trends in supplemental screening utilization.

Screening Guidelines and Supplemental Screening Tools: Assessment of the Adequacy of Patient-Provider Discussions.

To assess breast imaging radiologists' perceptions of the adequacy of provider-patient discussions regarding the benefits and risks of screening mammography and supplemental screening in women with elevated risk and dense breasts. A 36-item questionnaire developed by the Society of Breast Imaging Patient Care and Delivery Task Force was distributed electronically to Society of Breast Imaging members to evaluate patient communication, education, and screening practices. Data from the 11 items specifically pertaining to screening practices were analyzed. The response rate was 14% (275/1992). Seventy-four percent of survey respondents perceived provider-patient discussions regarding mammography screening guidelines as inadequate, and they agreed that provider-patient discussions regarding screening guidelines (82%) and supplemental screening for increased breast density (74%) should be standardized. Only 38% indicated that mammography screening guidelines are officially endorsed by their institution. Similarly, 37% reported that recommendations were up to the primary provider. Although most respondents include information about breast density in lay letters (73%) and radiology reports (89%), many feel that further patient education regarding breast density, supplemental screening, risk assessment, and screening guidelines should be performed by radiologists, and they are willing to provide additional patient education in these areas in practice. Survey respondents perceived current provider-patient discussions about the risks and benefits of breast cancer mammography screening and supplemental screening as inadequate and felt that standards should be developed. Respondents reported a willingness to take on patient education as part of their daily practice. These findings could inform future initiatives for radiologists to contribute to enhancing provider-patient education.

Supplemental Screening for Women with Dense Breasts: What Do Practicing Radiologists Recommend?

To evaluate radiologists' supplemental screening recommendations for women with dense breasts, at average, intermediate, or high risk of breast cancer, and to determine if there are differences between their recommendations for their patients, their friends and family, and themselves. This is an anonymous survey of Society of Breast Imaging (SBI) members. Demographics, knowledge of breast density as a risk factor, and recommendations for screening with digital breast tomosynthesis (DBT), ultrasound (US), and magnetic resonance imaging (MRI) in women with dense breasts, at average, intermediate, or high- risk of breast cancer were assessed. The likelihood of their recommending the screening test for their patients, their family and friends, and themselves was assessed on a Likert scale from 0 to 4 (0 = "not at all likely" to 4 = "extremely likely"). There were 295 responses: 67% were women, and breast imaging comprised 95% of their practice. Among participants, 53% correctly answered the question on relative risk of breast cancer when comparing extremely dense versus fatty breasts, and 57% when comparing heterogeneously dense versus scattered breasts. US is recommended at a relatively low rate (1.0-1.4 on the 0-4 scale), regardless of risk. DBT is recommended at a relatively high rate (2.5-3.0 on the 0-4 scale), regardless of risk status. MR is recommended mainly for those at high risk (3.6 on the 0-4 scale). Radiologists were more likely to recommend additional imaging for themselves than for their patients and their family and friends. For women with dense breasts, radiologists are "somewhat likely" to recommend US and "likely" to "very likely" to recommend DBT regardless of risk group. They are "very likely" to recommend MRI for high-risk groups.

Validation of the breast cancer surveillance consortium model of breast cancer risk.

In order to use a breast cancer prediction model in clinical practice to guide screening and prevention, it must be well calibrated and validated in samples independent from the one used for development. We assessed the accuracy of the breast cancer surveillance consortium (BCSC) model in a racially diverse population followed for up to 10years. The BCSC model combines breast density with other risk factors to estimate a woman's 5- and 10-year risk of invasive breast cancer. We validated the model in an independent cohort of 252,997 women in the Chicago area. We evaluated calibration using the ratio of expected to observed (E/O) invasive breast cancers in the cohort and discrimination using the area under the receiver operating characteristic curve (AUROC). In an independent cohort of 252,997 women (median age 50 years, 26% non-Hispanic Black), the BCSC model was well calibrated (E/O = 0.94, 95% confidence interval [CI] 0.90-0.98), but underestimated the incidence of invasive breast cancer in younger women and in women with low mammographic density. The AUROC was 0.633, similar to that observed in prior validation studies. The BCSC model is a well-validated risk assessment tool for breast cancer that may be particularly useful when assessing the utility of supplemental screening in women with dense breasts.

Evaluation of a Stratified National Breast Screening Program in the United Kingdom: An Early Model-Based Cost-Effectiveness Analysis.

To identify the incremental costs and consequences of stratified national breast screening programs (stratified NBSPs) and drivers of relative cost-effectiveness. A decision-analytic model (discrete event simulation) was conceptualized to represent four stratified NBSPs (risk 1, risk 2, masking [supplemental screening for women with higher breast density], and masking and risk 1) compared with the current UK NBSP and no screening. The model assumed a lifetime horizon, the health service perspective to identify costs (£, 2015), and measured consequences in quality-adjusted life-years (QALYs). Multiple data sources were used: systematic reviews of effectiveness and utility, published studies reporting costs, and cohort studies embedded in existing NBSPs. Model parameter uncertainty was assessed using probabilistic sensitivity analysis and one-way sensitivity analysis. The base-case analysis, supported by probabilistic sensitivity analysis, suggested that the risk stratified NBSPs (risk 1 and risk-2) were relatively cost-effective when compared with the current UK NBSP, with incremental cost-effectiveness ratios of £16,689 per QALY and £23,924 per QALY, respectively. Stratified NBSP including masking approaches (supplemental screening for women with higher breast density) was not a cost-effective alternative, with incremental cost-effectiveness ratios of £212,947 per QALY (masking) and £75,254 per QALY (risk 1 and masking). When compared with no screening, all stratified NBSPs could be considered cost-effective. Key drivers of cost-effectiveness were discount rate, natural history model parameters, mammographic sensitivity, and biopsy rates for recalled cases. A key assumption was that the risk model used in the stratification process was perfectly calibrated to the population. This early model-based cost-effectiveness analysis provides indicative evidence for decision makers to understand the key drivers of costs and QALYs for exemplar stratified NBSP.

Imaging Management of Breast Density, a Controversial Risk Factor for Breast Cancer.

Breast density is well recognized as an independent risk factor for the development of breast cancer. However, the magnitude of risk is controversial. As the public becomes increasingly aware of breast density as a risk factor, legislation and notification laws in relation to breast density have become common throughout the United States. Awareness of breast density as a risk factor for breast cancer presents new challenges for the clinician in the approach to the management and screening of women with dense breasts. The evidence and controversy surrounding breast density as a risk factor for the development of breast cancer are discussed. Common supplemental screening modalities for breast cancer are also discussed, including tomosynthesis, ultrasonography, and magnetic resonance imaging. A management strategy for screening women with dense breasts is also presented. The American College of Radiology recognizes breast density as a controversial risk factor for breast cancer, whereas the American Congress of Obstetricians and Gynecologists recognizes breast density as a modest risk factor. Neither organization recommends the routine use of supplemental screening in women with dense breasts without considering additional patient-related risk factors. Breast density is a poorly understood and controversial risk factor for the development of breast cancer. Mammography is a screening modality proven to reduce breast cancer-related mortality rates and is the single most appropriate tool for population-based screening. Use of supplemental screening modalities should be tailored to individual risk assessment.

Mammographic Breast Density and Breast Cancer Risk: Implications of the Breast Density Legislation for Health Care Practitioners.

Breast density has emerged as a critical phenotypic marker of increased breast cancer risk. The breast density legislation, passed in multiple states, requires patient notification of the implications of the breast density on breast cancer risk and screening. Supplemental screening may be suggested in the state regulation; however, there are limited data to guide conversations with patients. This article will review the current state of supplemental screening in women with dense breasts and discuss theories of the mechanism of action. Guidance is provided to assist in shared decision making and appropriate patient counseling.

Molecular Imaging Approaches for Supplemental Screening in Women at Increased Breast Cancer Risk.

Mammography is an effective screening method that reduces breast cancer mortality ([1][1]). However, mammography is not a perfect test and its sensitivity is diminished in women with dense breast tissue ([2][2]). For women at increased breast cancer risk, the use of imaging modalities in addition to

Breast Density Assessment, Risk, and Significance in the Screening of Breast Cancer

Every breast is composed of varying degrees of fibroglandular breast tissue and fatty tissue. Breast density reflects the amount of fibroglandular tissue present relative to the amount of fat, and may be assessed either qualitatively or quantitatively. The most common classification of breast density used clinically is the qualitative, subjective scale from the Breast Imaging Reporting and Data System 5th edition categorizing breast density using mammography as almost entirely fatty, scattered areas of fibroglandular density, heterogeneously dense, and extremely dense (D’Orsi et al. in Breast Imaging Reporting and Data System: ACR BI-RADS, 2012). The latter two categories are usually considered “dense” breasts in terms of risk assessment. Though dense breasts likely contribute as a small independent risk factor for breast cancer, dense breast tissue on mammography may also obscure an underlying cancer, making it more difficult for the cancer to be detected mammographically. Several states have now passed laws requiring patients to be notified if they have dense breasts and their potential options for supplemental screening (Freer in Radiographics 35:302–315, 2015; Are You Dense Advocacy, Inc. D.E.N.S.E. ® State Efforts in http://areyoudenseadvocacy.org/dense/, 2015). Presently, however, evidence in support of supplemental screening in women with dense breasts is limited, often leading to confusion for both patients and clinicians, especially when supplemental screening methods may not be covered by insurance companies (Freer in Radiographics 35:302–315, 2015; Slanetz et al. in N Engl J Med 372:593–595, 2015). Newer models of calculating a patient’s lifetime risk of breast cancer while incorporating breast density may prove useful in developing future supplemental screening recommendations for women with dense breasts (Warwick et al. in Breast Cancer Res 16:451, 2014). The purpose of this article is to familiarize the radiologist with how breast density is assessed, how increased breast density may diminish sensitivity of screening mammography, and which patient populations with dense breasts may benefit from supplemental screening based on risk stratification.

Mammographic breast density: impact on breast cancer risk and implications for screening.

Mammographic breast density is rapidly becoming a hot topic in both the medical literature and the lay press. In the United States, recent legislative changes in 19 states now require radiologists to notify patients regarding breast density as well as the possible need for supplemental screening. Federal legislation regarding breast density notification has been introduced, and its passage is likely on the horizon. An understanding of the context, scientific evidence, and controversies surrounding the topic of breast density as a risk factor for breast cancer is critical for radiologists. The current state of evidence is presented regarding supplemental screening for women with dense breasts, including the use of digital breast tomosynthesis, whole-breast ultrasonography, and gadolinium-enhanced magnetic resonance imaging. A review of current practice guidelines and additional sources of information will improve radiologists' understanding of the relevant subject of breast density and enable them to respond appropriately to questions from patients, clinicians, and the media.

Abstract P2-01-01: Impact of California breast density notification law SB 1538 on California women and their health care providers

Abstract Purpose: To describe the impact of California Breast Density Notification law (SB 1538) on policy development, policy implementation and supplemental screening strategies within California medical facilities. SB 1538 mandates that breast density information be given to patients but provides no funding for supplemental screening, no guidance on how to triage women for supplemental screening nor which imaging modalities to use. Methods: As a result of the law, the California Breast Density Information Group (CBDIG) formed from academic and private practice radiologists and risk assessment experts, reviewing scientific literature and nationally recognized guidelines to provide evidence-based recommendations regarding supplemental screening in women with dense breast tissue. A survey was sent to 6 academic and 3 large private practices in California to record their experience in implementing the law. Results: CBDIG created a public, institution-neutral, evidence-based website, “breastdensity.info”, that includes information and recommendations regarding supplemental breast screening, with triage for supplemental MRI or US based on breast cancer risk assessment using genetic or family history risk models. CBDIG facilities worked with referring health care providers to inform them of the new law, educated their staff and technologists on implementing policy, and developed notification strategies to comply with legislation. The survey showed that all 9 facilities recommended supplemental screening based on family history models or genetic testing. 3/9 calculated breast cancer risk in the breast imaging clinic, and 2/9 emailed a risk survey to the patient. 3/9 reported risk in the radiology report, and 1/9 reported risk only if the patient was high risk. Risk assessments were performed by technologists and risk assessment health practitioners. 8/9 facilities estimated breast density by visual methods, and 1/9 by computer. All facilities performed screening breast MRI, 4/9 performed handheld screening US, and 2/9 tomosynthesis. 1/9 obtained tomosynthesis in anticipation of the law, 2/9 are trying to obtain automated whole breast US, and 3/9 are trying to obtain tomosynthesis. Facilities expressed concerns about additional false-positive biopsies produced by supplemental screenings, out-of-pocket expenses for women, and disparities (low income) in notified populations. Conclusion: SB 1538 resulted in the formation of the CBDIG and the website, “breastdensity.info”. Our survey showed variations in imaging modalities available and policy implementation at each facility. Given that several states currently have breast density laws or have laws that will become effective in the near future, it is important for breast imagers and clinicians to be informed of the current literature, realize the variation in equipment and policies at various facilities, and develop recommendation strategies to guide patients seeking supplemental screening. We plan to follow up this survey with a larger survey of the Society of Breast Imagers at a later date. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-01-01.