TPS9611 Background: A significant risk factor for melanoma is presence of atypical/dysplastic nevi (A/DN), and evidence suggests a 10-fold increased risk of new primary melanoma with A/DN. 1 Patients with prior melanoma and multiple A/DN are thus reasonable targets for therapeutic prevention due to high risk of additional melanoma. Currently, no preventative systemic agent for melanoma is approved. Sulforaphane, an isothiocyanate of cruciferous vegetables, demonstrates therapeutic prevention potential in multiple clinical trials. 2 3 Topical sulforaphane mitigates effects of UV radiation, a primary driver of melanoma development, in mouse and human skin. 4 The proposed mechanism involves alterations of transcription factor Nrf2, an antioxidant modulator, and IL-6/STAT-3 pathways in A/DN and melanoma. 5 6 7 Our team conducted a phase I trial of oral sulforaphane for 28 days in 17 patients with prior melanoma and ≥ 2 A/DN. 8 Statistically significant decreases in several serum pro-inflammatory cytokines were reported with no dose-limiting toxicities. This phase II trial aims to elucidate effects of daily sulforaphane on A/DN lesions and compare pigmentation change to placebo over one year. We hypothesize sulforaphane will demonstrate a greater decrease in total area of pigmented nevocellular nevi (both A/DN and banal nevi) vs. placebo as documented by serial digital photography. Methods: This phase II trial (NCT07040280) will assess impact of daily sulforaphane for 12 months vs. placebo on total area, quantity, and features of A/DN. Patients with ≥ 3 clinical A/DN (≥ 5 mm diameter with macular component, and ≥2 features of ill-defined borders, color variegation, uneven contour, or erythema) and a history of early stage-melanoma are eligible. Enrolled patients will undergo a baseline clinical skin exam and scheduled follow-up exams every 3 months. Photography of index A/DN and a standardized area of the posterior trunk, excisional biopsy of an A/DN, and peripheral blood sampling will be performed at baseline, 3 months, and 12 months. The primary endpoint is effect of sulforaphane vs. placebo on change in total area of pigmented nevocellular nevi on the posterior trunk at 12 months, calculated by Derma-AI image analysis software. 9 Secondary endpoints are number of posterior truncal nevi with moderate to significant changes in area, changes in A/DN features/area, and assessment of the safety/tolerability of sulforaphane. Exploratory endpoints include effects on circulating cytokine and chemokine levels assessed by multiplex technology, impact on A/DN immune cell infiltration by histopathology and immunochemistry, and evaluation of prespecified A/DN features at each timepoint. Outcome measures will be compared between arms over serial timepoints by Wilcoxon rank sum test. The study is open for enrollment with accrual goal of 120 patients.

10506 Background: Excess weight is a key modifiable risk factor for breast cancer. Glucagon-like peptide-1 receptor agonists (GLP-1) promote weight loss and improve markers of metabolic health. However, the effect of GLP-1 on breast cancer risk among women eligible for breast cancer screening remains unclear. Methods: We conducted a retrospective, time-dependent cohort study from January 1, 2022, to June 30, 2025, using electronic health records. We identified 217,025 unique patients who underwent breast imaging, restricting the sample to women aged 45 to 80 years with a BMI greater than 25 and a documented imaging outcome (n=94,827; median age 61). The primary outcome was breast cancer detection. GLP-1 use was defined as a first prescription prior to the exam date and assessed in relation to race, ethnicity, age, and type 2 diabetes. To address potential confounding between these covariates and GLP-1 exposure, we performed one-to-one, case-control matching using propensity scores based on age, race, ethnicity, highest BMI, breast density, and type 2 diabetes diagnosis. Results: Among 94,827 women, 2,314 (2.4%) were diagnosed with breast cancer during the study period, while 92,513 (97.6%) were not. Of the total, 15,107 (15.9%) had GLP-1 exposure, and 79,720 (84.1%) did not. Among those exposed to GLP-1, 249 (1.65%) developed breast cancer, while 14,858 (98.4%) did not. Among women without exposure to GLP-1, there were 2065 (2.6%) women with breast cancer and 77,655 (97.4%) of women without breast cancer. GLP-1 exposure was associated with a lower incidence of breast cancer (OR 0.630 (0.552, 0.720 ); p<0.0001). In the matched logistic regression analysis (30,214 observations; 581 cancer cases), GLP-1 exposure prior to the exam date was associated with a lower incidence of breast cancer (OR 0.746, 95% CI: 0.632–0.880; p<0.0005). Conclusions: In this large observational study of women undergoing breast imaging at a major academic center, GLP-1 treatment was associated with a significantly lower incidence of breast cancer after accounting for age, race, ethnicity, BMI, breast density, and type 2 diabetes status. These findings support the need for prospective trials investigating incretin medications for breast cancer prevention. Matched case-control contingency table for GLP-1 exposure prior to exam date and breast cancer. No cancer Total GLP-1 249 (1.65%) 14858 (98.35%) 15107 No GLP-1 332 (2.20%) 14775 (97.80%) 15107 Total 581 (1.92%) 29633 (98.08%) 30214

Background: The primary aim of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) is to determine whether women randomly assigned to be screened through 3-5 rounds with tomosynthesis (TM) have fewer advanced cancers than the population screened with digital mammography (DM) over 3-8 years after entry. In addition, there are 15 secondary aims with data being collected in the areas of imaging assessment, medical physics, breast biology and pathology, long-term follow-up, and health care utilization. Women ages 45 to 74 are eligible to participate. The study will enroll 108,508 women. Participants may also volunteer to contribute blood and/or buccal smears to the TMIST biorepository. Approximately 70% of TMIST participants have agreed to do so. Because of the size of the TMIST study and vast amount of data to be collected, there is an opportunity for investigators to utilize TMIST data to support various research questions not covered in TMIST. Methods:The TMIST study team developed a process where investigators who would like access to the TMIST data can submit a concept while the trial is ongoing for access to data in a protected manner. The process starts with the project investigator reaching out to the TMIST study chair. If the study chair, lead statistician, and ECOG-ACRIN (EA) co-Principal Investigator think the project has promise; a timeline for when the project could take place (either (1) during the TMIST clinical trial or (2) after the end of the trial and publication of the primary paper) is developed. The next steps involve reviews by the TMIST Data Safety and Monitoring Board and the EA Executive Review Committee. All ancillary projects proposed will require an external funding plan and budget before the project moves out of concept review inside of EA. Once the project concept clears all required EA approvals it then goes to the National Cancer Institute (NCI) Division of Cancer Prevention (DCP) for their approval. NCI Central Institutional Review Board (CIRB) approval is also required for the project to start while the trial is still active but is not sought until funding has been received. Two projects have secured external funding, have completed the EA committees’ review processes, and have received NCI approval. One is a case control study assessing short-term breast cancer risk through image-based analysis of screening mammograms (Project PI: Jon Steingrimsson, PhD, Brown University). The second is a case control study to assess the impact of breast compression pressure versus force in screening mammography on the likelihood of developing interval breast cancers (Project PIs: Etta Pisano, MD and Aili Maki, PhD, University of Toronto). Both projects involve analysis of images where software is being applied to TMIST images on computer systems controlled by EA IT personnel. Both projects are expected to be completed in the next year. Two additional projects have been approved for grant submission through the process described above. The PreSCRiB study (PI: Elizabeth Burnside, MD MPH, U of Wisconsin) will utilize Machine Learning applied to TMIST and All of Us data, including genetics, mammograms, social determinates of health and other data to develop individualized screening strategies for women. The second project (PI; Marc Ryser, PhD, Duke University) will utilize TMIST data to validate an algorithm the investigators have developed to assess overdiagnosis. Another project that is in development and will likely be submitted for approval and funding in the next 6-9 months is a collaboration between TMIST and UK-based clinical trial PROSPECTS study teams to compare rates of all cancers and advanced cancers for annual, biennial, and 3-year screening, with analysis by age, race, ethnicity, breast density and other factors. The ongoing TMIST study, as of June 24, 2024, has enrolled 101,394 women. Total enrollment is expected by late 2024 or early 2025. Follow-up on enrolled participants is expected to end in early 2028. Citation Format: Etta Pisano, Constantine Gatsonis, Mitchell Schnall, Melissa Troester, Elodia Cole , Jean Cormack, Jon Steingrimsson, Ilana Gareen, Martin Yaffe, Laura Collins, Amarinthia Curtis, Ruth Carlos, Kathy Miller, Christopher Comstock. Conducting Ancillary Studies during an Active NCTN/NCORP Screening Trial – The TMIST (ECOG-ACRIN EA1151) Experience [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P1-01-05.

This paper explores the design considerations and hurdles encountered by the CHinA National CancEr Screening (CHANCES) Trial and the Tomosynthesis Mammographic Imaging Screening Trial (TMIST), both aimed at advancing cancer screening research. Before population-based cancer screening programs are launched, it is important to have confidence that the potential benefits of the screening process and resulting interventions outweigh harms, an ethical imperative because the people actively invited into the programs are relatively healthy. Large randomized screening trials provide the strongest, direct evidence regarding the balance of benefits and harms. The implementation of cancer screening programs involves a series of steps, with outcomes influenced by factors such as the prevalence of the disease, availability of effective treatment within the health-care system, and acceptance by the target population—all of which may vary considerably from country to country. This paper examines how these factors shaped the design and statistical approach of the CHANCES Trial for lung and colorectal cancers and the TMIST trial for breast cancer. We discuss the rationale, objectives, endpoint definitions, trial designs, and sample size considerations, highlighting both the challenges and opportunities presented in different settings. Ultimately, the goal is to foster collaboration and develop screening strategies that are scientifically robust and practically effective for diverse populations worldwide.

BACKGROUND:Transportation barriers significantly limit participation in breast cancer screening trials among Hispanic women, exacerbating disparities in breast cancer outcomes and underrepresentation in clinical research. Rideshare programs have emerged as a potential solution, but their long-term sustainability remains underexplored. Understanding sustainability capacity is critical to ensuring these programs can address structural barriers, promote health equity, and improve outcomes for underserved populations. The aim of this study is to evaluate sustainability capacity of a no-cost rideshare program and to identify potential strategies to support sustainability. METHODS:This explanatory, sequential, mixed-methods study evaluated the sustainability capacity of a no-cost rideshare program aimed at increasing Hispanic women's participation in the Tomosynthesis Mammographic Imaging Screening Trial. Analyses and data integration were guided by the Capacity for Sustainability Framework. Average domain scores on the Program Sustainability Assessment Tool survey were calculated ranging from 1 to 7, with higher scores indicating higher levels for each domain, and structured interviews were analyzed using a rapid qualitative approach. Program Sustainability Assessment Tool and interview findings were integrated using a joint display. RESULTS:Survey responses (n = 37) indicated strengths in environmental support (mean score: 5.4) and partnerships (6.0), but challenges in funding stability (4.2) and strategic planning (4.5). Interview findings emphasized the importance of program champions and collaborative partnerships and highlighted gaps in securing diverse funding sources and engaging institutional leadership in strategic planning. Participants identified opportunities to strengthen communication, evaluate program impact, and adapt processes to meet evolving needs. DISCUSSION:Strong partnerships and champions supported the program's initial success, but funding instability and insufficient strategic planning threaten sustainability. Future efforts should prioritize securing diverse funding, engaging leadership, and fostering collaboration to scale rideshare programs, thereby reducing disparities and advancing equity in breast cancer screening and research participation.

HomeRadiologyVol. 311, No. 1 PreviousNext CommunicationsLetters to the EditorCaution on the CONTRRAST TrialSarah Eskreis-Winkler , Maxine S. Jochelson, Katja Pinker, Janice S. Sung, Christopher ComstockSarah Eskreis-Winkler , Maxine S. Jochelson, Katja Pinker, Janice S. Sung, Christopher ComstockAuthor AffiliationsDepartment of Radiology, Memorial Sloan-Kettering Cancer Center, New York, 300 E 66th St, New York, NY 10065email: [email protected]Sarah Eskreis-Winkler Maxine S. JochelsonKatja PinkerJanice S. SungChristopher ComstockPublished Online:Apr 9 2024https://doi.org/10.1148/radiol.233188MoreSectionsFull textPDF ToolsAdd to favoritesCiteTrack CitationsPermissionsReprints ShareShare onFacebookXLinked In Reference1. Phillips J, Mehta TS, Portnow LH, Fishman MDC, Zhang Z, Pisano ED. Comparison of Contrast-enhanced Mammography with MRI Utilizing an Enriched Reader Study: A Breast Cancer Study (CONTRRAST Trial). Radiology 2023;309(2):e230530. Link, Google ScholarArticle HistoryPublished online: Apr 09 2024 FiguresReferencesRelatedDetailsRecommended Articles Recall and Outcome of Screen-detected Microcalcifications during 2 Decades of Mammography Screening in the Netherlands National Breast Screening ProgramRadiology2020Volume: 294Issue: 3pp. 528-537Digital Breast Tomosynthesis May Not Provide Optimal Surveillance of Breast Cancer SurvivorsRadiology2020Volume: 298Issue: 2pp. 317-318Data Do Not Support Semiannual Screening US after MRI, and Screening Mammography after MRI Has Limited BenefitRadiology2023Volume: 307Issue: 5Contrast-enhanced Mammography: Current Applications and Future DirectionsRadioGraphics2019Volume: 39Issue: 7pp. 1907-1920Supplemental Breast Cancer Screening in Women with Dense Breasts and Negative Mammography: A Systematic Review and Meta-AnalysisRadiology2023Volume: 306Issue: 3See More RSNA Education Exhibits 2022 New Trends in Breast Density - What Should We Know?Digital Posters2022Let's Talk about Next-Generation Breast Cancer Screening Programs: How Should We Do? What Should We Use?Digital Posters2020AI for Mammography: What Radiologists Need to KnowDigital Posters2022 RSNA Case Collection Ductal carcinoma in situRSNA Case Collection2020Ductal Carcinoma In SituRSNA Case Collection2022Primary breast amyloidosisRSNA Case Collection2020 Vol. 311, No. 1 Metrics Altmetric Score PDF download

Abstract Background The United States Preventative Services Task Force in their 2023 recommendations identified areas where more research data is needed to inform future breast cancer screening recommendations. Research areas identified are: improve clinicians and patients understanding and evaluation of dense breast tissue on a screening mammogram, benefits and harms of supplemental screening using ultrasound or MRI for women with dense breasts, health outcomes such as rates of breast cancer diagnosis requiring treatment, rates of advanced breast cancers diagnosed across consecutive screening rounds, and breast cancer-associated morbidity and mortality, causes of increased risk of breast cancer mortality in black women across spectrum of stages and biomarker patterns, understand why black women are more likely to be diagnosed with breast cancers that have biomarker patterns that are indicative of poor health outcomes, assess benefits/harms differences between annual and biennial screening for breast cancer in women overall and if there are differences between black and white women, approaches to reduce the risk of overdiagnosis leading to overtreatment of breast lesions found at screening that may not cause morbidity and mortality, natural history of DCIS, and identify prognostic indicators of breast tumors that are unlikely to affect quality or length of life. Methods The ongoing TMIST study, currently with 88,801 asymptomatic women presenting for screening mammography ages 45-74 enrolled out of 128,905, could contribute to scientific evidence to support the above research areas through existing study aims and planned ancillary studies. Supplemental Screening with US and MRI: TMIST PreSCRIB will utilize Machine Learning applied to TMIST and All of Us data, including genetics, mammograms, social determinates of health and other data to recommend individualized screening strategies for women. DxMRI is a study where women will get AbMRI at time of Dx work-up. There are plans to use these examinations plus supplemental screening MRIs performed on TMIST subjects in an enriched reader study to evaluate the role of supplemental screening MRI in moderate risk women. Rates of breast cancer treatment, consecutive screening, morbidity, and mortality: TMIST’s primary outcome is the proportion of women experiencing an advanced breast cancer and needing treatment. TMIST is also collecting information on health care utilization following a cancer diagnosis, including types of treatment given, and costs data from the screening and diagnostic work-up visits, and mortality data for study participants. Increased risk of breast cancer mortality in black women: TMIST is performing PAM50 plus p53 status, immune profile, DNA repair phenotype, and 21-gene recurrence assay on all breast cancers and a subset of benign tissue. Blood and buccal smears might also help address this issue. Ongoing work, funded by the Susan B. Komen Foundation, focuses on improving Black participation in TMIST Biorepository (currently about 45% participation of the 21% of TMIST US black subjects). Surveys are planned on perceived racism and social determinates of health as part of DxMRI Study. Screening Frequency: We are developing a collaboration with the UK-based clinical trial PROSPECTS to compare rates of all cancers and advanced cancers for annual, biennial, and 3-year screening. Overdiagnosis, natural history of DCIS, prognostic indicators of breast tumors not impacting quality of life: PRoGram- will use radiomics, genomics and pathomics to develop a greater understanding of the variability of the non-advanced cancers diagnosed in the TMIST population, including DCIS. It is hoped that this model will provide greater understanding of the risk of poor outcomes for women diagnosed with lower risk cancers, including DCIS. Citation Format: Etta Pisano, Constantine Gatsonis, Mitchell Schnall, Melissa Troester, Elodia Cole, Jean Cormack, Ilana Gareen, Martin Yaffe, Laura Collins, Amarinthia Curtis, Ruth Carlos, Kathy Miller, Christopher Comstock. Addressing USPSTF 2023 Identified Key Gaps in Knowledge in Breast Cancer Screening through TMIST (ECOG-ACRIN EA1151) or its Ancillary Studies [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 PO3-19-03.

Diffusion weighted imaging (DWI) holds great potential in improving specificity of findings detected on contrast enhanced breast MRI. Restriction spectrum imaging (RSI), an advanced diffusion imaging model, has potential in discriminating between malignant and fibroglandular breast tissue. In this abstract, we evaluate RSI’s performance in differentiating malignant from benign lesions in a prospective study performed on a breast screening population. All lesions were biopsy proven. The breast RSI model allowed discrimination between malignant, high-risk and low-risk benign lesions and healthy fibroglandular tissue.

Multicenter clinical trials in radiology have long been a mainstay in our ability to translate clinical research to widespread clinical practice. They help ensure that promising results obtained by a single academic institution will generalize to the diversity of patients, imaging equipment and practice types present in the wider community. Multicenter studies reduce potential biases that may result from single institution results, promote health equity, and inform public policy. Outcomes data from multicenter trials have been used to support favorable recommendations from governmental agencies such as US Preventive Services Task Force and coverage and payment policy decisions from the Centers for Medicare and Medicaid Services (CMS) ( 1 Pisano ED Gatsonis C Hendrick E et al. Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med. 2005; 353: 1773-1783 Crossref PubMed Scopus (1568) Google Scholar , 2 National Lung Screening Trial Research TeamReduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011; 365: 395-409 Crossref PubMed Scopus (7067) Google Scholar ). The American College of Radiology (ACR) has a long history of supporting multicenter trials in diagnostic radiology and radiation oncology. These trials typically involve standardized protocol development, site management, the development of study data dictionaries and data collection and cleaning, independent interpretation of imaging findings and centralized support to collate, analyze and publish the results. Many of these trials have been funded by governmental agencies such the National Cancer Institute while others have been sponsored by industry and other institutions.

PURPOSE:A comprehensive, centrally-monitored physics quality control (QC) program was developed for the Tomosynthesis Imaging Screening Trial (TMIST), a randomized controlled trial of digital breast tomosynthesis (TM) versus digital mammography (DM) for cancer screening. As part of the program, in addition to a set of phantom-based tests, de-identified data on image acquisition and processing parameters were captured from the DICOM headers of all individual patient images in the trial. These data were analyzed to assess the potential usefulness of header data from digital mammograms and tomosynthesis images of patients for quality assurance in breast imaging. METHODS:Data were automatically extracted from the headers of all de-identified patient mammograms and tomosynthesis images in the TMIST study. Image acquisition parameters and estimated radiation doses were tracked for individual sites, systems and across system types. These parameters included (among others) kV, target/filter use, number of acquired views per examination, AEC mode, compression thickness and force and detector temperature. Consistency of manually entered study data parameters (subject ID, screening time-point) from TMIST was evaluated. Preliminary observations from the program are presented. RESULTS:We report on data from 812 651 images from 135 525 examinations acquired between October, 2017 and December, 2022. Data came from 6 system models from 3 manufacturers. There was greater variability both in the number of views used and in the estimated (proxy) doses received in DM exams compared to TM. Mean proxy doses per examination varied among manufacturers from 2.76-4.54 mGy for DM and 3-4.84 mGy for the tomosynthesis component in the TM arm with maximum examination proxy doses of 20 and 26 mGy for DM and TM respectively. Mean proxy doses per examination for the combination examination in TM (tomosynthesis plus digital mammography) varied from 6.6 to 7.6 mGy among manufacturers with a maximum of 44.5 mGy. CONCLUSIONS:Overall, modern digital mammography and tomosynthesis systems used in TMIST have operated very reliably. Doses vary considerably due to variation in the number of views per examination, thickness and fibro-glandularity of the breast, and choices in the use of synthesized versus actual 2D mammography in the TM examination. These data may also be useful in predicting equipment problems. Header information is valuable not only for automated QC, but also for cross-checking accuracy and consistency of data in a clinical study.

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.

Background Despite growing interest in using contrast-enhanced mammography (CEM) for breast cancer screening as an alternative to breast MRI, limited literature is available. Purpose To determine whether CEM is noninferior to breast MRI or abbreviated breast MRI (AB MRI) and superior to two-dimensional mammography in an asymptomatic population simulating those who would present for screening and then undergo diagnostic work-up. Materials and Methods This enriched reader study used CEM and MRI data prospectively collected from asymptomatic individuals at a single institution from December 2014 to March 2020. Case sets were obtained at screening, as part of work-up for a screening-detected finding, or before biopsy of a screening-detected abnormality. All images were anonymized and randomized, and all 12 radiologists interpreted them. For CEM interpretation, readers were first shown low-energy images as a surrogate for digital mammography and asked to give a forced Breast Imaging Reporting and Data System score for up to three abnormalities. The highest score was used as the case score. Readers then reviewed the full CEM examination and scored it similarly. After a minimum 1-month washout, the readers similarly interpreted AB MRI and full MRI examinations. Receiver operating characteristic analysis, powered to test CEM noninferiority to full MRI, was performed. Results The study included 132 case sets (14 negative, 74 benign, and 44 malignant; all female participants; mean age, 54 years ± 12 [SD]). The mean areas under the receiver operating characteristic curve (AUCs) for digital mammography, CEM, AB MRI, and full MRI were 0.79, 0.91, 0.89, and 0.91, respectively. CEM was superior to digital mammography (P < .001). No evidence of a difference in AUC was found between CEM and AB MRI and MRI. Conclusion In an asymptomatic study sample, CEM was noninferior to full MRI and AB MRI and was superior to digital mammography. Clinical trial registration no. NCT03482557 and NCT02275871 © RSNA, 2023 Supplemental material is available for this article.

Purpose Cancer detection rate (CDR), an important metric in the mammography screening audit, is designed to ensure adequate sensitivity. Most practices use biopsy results as the reference standard; however, commonly ascertainment of biopsy results is incomplete. We used simulation to determine the relationship between the cancer ascertainment rate of biopsy (AR-biopsy), CDR estimation, and associated error rates in classifying whether practices and radiologists meet the established ACR benchmark of 2.5 per 1,000. Materials and Methods We simulated screening mammography volume, number of cancers detected, and CDR, using negative binomial and beta-binomial distributions, respectively. Simulations were performed at both the practice and radiologist level. Average CDR was based on linearly rescaling a published CDR by the AR-biopsy. CDR distributions were simulated for AR-biopsy between 5% and 100% in steps of five percentage points and were summarized with boxplots and smoothed histograms over the range of AR-biopsy, to quantify the proportion of practices and radiologists meeting the ACR benchmark at each level of AR-biopsy. Results Decreasing AR-biopsy led to an increasing probability of categorizing CDR performance as being below the ACR benchmark. Our simulation predicts that at the practice level, an AR-biopsy of 65% categorizes 17.6% below the benchmark (compared to 1.6% at an AR-biopsy of 100%), and at the radiologist level, an AR-biopsy of 65% categorizes 34.7% as being below the benchmark (compared to 11.6% at an AR-biopsy of 100%). Conclusions Our simulation demonstrates that decreasing the AR-biopsy (in currently clinically relevant ranges) has the potential to artifactually lower the assessed CDR on both the practice and radiologist levels and may, in turn, increase the chance of erroneous categorization of underperformance per the ACR benchmark.

Despite efforts at many institutions, nationally, women still lag behind their male counterparts in leadership, promotion, and seniority. In this paper, we describe the efforts to improve the environment for women faculty at one large academic medical center through the creation of an Association of Professional Women in Medical Sciences. Over the years, the group has helped influence policies that directly affect women faculty, provided high-yield programming on topics related to women's success, and created interprofessional networking opportunities for women faculty. We describe the challenges and successes of this group to serve as a model and inspiration for other institutions.

Objective Measuring the cost of performing breast imaging is difficult in healthcare systems. The purpose of our study was to evaluate this cost using time-driven activity-based costing (TDABC) and to evaluate cost drivers for different exams. Methods An IRB-approved, single center prospective study was performed on 80 female patients presenting for breast screening, diagnostic or biopsy exams from July 2020 to April 2021. Using TDABC, data were collected for each exam type. Included were full-field digital mammography (FFDM), digital breast tomosynthesis (DBT), contrast-enhanced mammography (CEM), US and MRI exams, and stereotactic, US-guided and MRI-guided biopsies. For each exam type, mean cost and relative contributions of equipment, personnel and supplies were calculated. Results Screening MRI, CEM, US, DBT, and FFDM costs were $249, $120, $83, $28, and $30. Personnel was the major contributor to cost (60.0%-87.0%) for all screening exams except MRI where equipment was the major contributor (62.2%). Diagnostic MRI, CEM, US, and FFDM costs were $241, $123, $70, and $43. Personnel was the major contributor to cost (60.5%-88.6%) for all diagnostic exams except MRI where equipment was the major contributor (61.8%). Costs of MRI-guided, stereotactic and US-guided biopsy were $1611, $826, and $356. Supplies contributed 40.5%-49.8% and personnel contributed 30.7%-55.6% to the total cost of biopsies. Conclusion TDABC provides assessment of actual costs of performing breast imaging. Costs and contributors varied across screening, diagnostic and biopsy exams and modalities. Practices may consider this methodology in understanding costs and making changes directed at cost savings.

TPS10614 Background: The ECOG-ACRIN Tomosynthesis Mammographic Imaging Screening Trial (TMIST), which opened in 2017, is a randomized trial designed to assess whether Tomosynthesis Mammography (TM) should replace Digital Mammography (DM) for breast cancer screening. It is hypothesized that women assigned to TM for 3-5 screening rounds will have fewer advanced breast cancers than the women assigned to DM. Advanced cancers are those that have distant metastases or positive nodes, are invasive tumors greater than or equal to 2.0 cm in size, or are invasive tumors greater than 1.0 cm in size that are triple negative or HER 2+. The initially planned enrollment of 164,946 women was due to be completed by the end of 2020, with follow-up concluded by 2025. There were substantial challenges in meeting this timeline, including the organizational and funding structure of the NCI National Clinical Trials Network which is dependent upon sites using their existing staffing resources (not always readily available at the time of study activation). This led to longer than anticipated start of enrollment for most interested sites and lower than anticipated annual enrollment per participating site based ultimately on the staffing support that could be allocated to manage TMIST. In addition, research staffing shortages and periodic research operations closures due to COVID-19 have also impacted enrolling TMIST sites, though unevenly, since the start of the pandemic. Enrollment plateaued at approximately 2,100 subjects per month by the end of 2020. With that accrual rate expected, the trial design was modified to reduce the sample size so that the study could be completed by 2027. Methods: With the approval of the NCI CIRB, we changed how the primary endpoint measure for TMIST is assessed from the number of advanced cancers that occur by 4.5 years after randomization to the time from randomization to occurrence of advanced cancers. All advanced cancers occurring within 7 years of randomization are now included and all participants followed for at least three years. In addition, the power of the study of the study was modified from 0.9 to 0.85, while the originally assumed effect size at 4.5 years was retained These changes allowed a reduction of sample size to 128,905, with subject recruitment projected to end in 2024. As of February 14, 2022, there are 125 sites open, 114 in the U.S. and 11 in other countries, with an additional 31 sites planning to open. As of February 14, 2022, a total of 63,845 women have been enrolled in the trial worldwide at 115 sites, with 20% of US participants self-identifying as belonging to minority racial and ethnic groups and 70% consenting to optional blood and/or buccal cell collection. Clinical trial information: NCT03233191.

Despite breast cancer screening rates that exceed those of White women, 26 Black women are diagnosed with more advanced stages of breast cancer.More worrisome, Black women endure higher rates of falsepositive screening results, an unfavorable outcome implicated in an increased risk of breast cancer.Additionally, elevated anxiety, stress, financial burden, [27][28][29][30][31][32] and paradoxically, reduced breast cancer screening 33

91 Background: Most screening clinical trials are not representative of the populations susceptible to disparities in breast cancer outcomes. Strategies are needed to address known structural barriers to clinical trial participation. We partnered with a federally qualified health center to provide no-cost ride-share services as a strategy to facilitate enrollment of uninsured, Hispanic women in Maricopa County, Arizona into a national trial offering no-cost mammography screening. Objective: This pilot survey study explored the feasibility and experiences of uninsured, Hispanic women with a no-cost ride share program as part of the National Cancer Institute funded ECOG-ACRIN clinical trial, TMIST, studying mammography screening at the Mayo Clinic Arizona in Phoenix. Methods: Participants completed a validated survey by phone and interview-style. Survey items assessed women’s use of and experiences with the ride share service including barriers, benefits, and if the ride share service facilitated their participation in the screening trial. Descriptive statistics were calculated using SAS. Results: A total of 30 women completed the survey (response rate = 30/33). All women first-time Mayo Clinic trial participants and 90% lived at least 30 minutes away from trial facility. The mean age of women was X years, 90% had a high school degree or less, and 97% were Spanish speaking. Most women (73.7%) said that travel distance was a barrier to participation in prior clinical trials. A large proportion of women (73%) reported using ride share services for this trial and all agreed that the ride service made it easier for them to attend their trial visit. Nearly 1/3 (64%) said that they were uncertain or would not have been able to participate without the ride-share as an option. Among women using the ride share service, the main benefits of the program included at-home pick up and the service being of no-cost. Other benefits included flexible timing (86%) and one-on-one service (86%). The primary barrier of the program was the driver not speaking the dominant native language (27.3%). Conclusions: Despite lengthy travel distances, women reported overwhelming positive experiences with the no-cost ride share program and agreed that the service helped facilitate their participation in the clinical trial. Thus, no-cost ride share programs are a promising and feasible strategy to reduce barriers to clinical trial participation among historically underserved populations. Future studies should continue to explore the benefits and sustainability of ride-share programs, including benefits to clinical trial retention.