An institutional strategy to increase minority recruitment to therapeutic trials.

PURPOSE: Participation in therapeutic clinical trials rarely reflects the race and ethnic composition of the patient population. To meet National Institutes of Health-mandated goals, strategies to increase participation are required. We present a framework for institutional enhancement of minority clinical trial accrual. METHODS: We implemented structural changes on four levels to induce and sustain minority accrual to clinical trials: (1) leadership support; (2) center-wide policy change; (3) infrastructural process control, data analysis, and reporting; and (4) follow-up with clinical investigators. A Protocol Review and Monitoring Committee reviews studies and monitors accrual, and the Program for the Elimination Cancer Disparities leads efforts for proportional accrual, supporting the system through data tracking, Web tools, and feedback to investigators. RESULTS: Following implementation in 2005, minority accrual to therapeutic trials increased from 12.0 % in 2005 to 14.0 % in 2010. The "rolling average" minority cancer incidence at the institution during this timeframe was 17.5 %. In addition to therapeutic trial accrual rates, we note significant increase in the number of minorities participating in all trials (therapeutic and nontherapeutic) from 2005 to 2010 (346-552, 60 % increase, p < 0.05) compared to a 52 % increase for Caucasians. CONCLUSIONS: Implementing a system to aid investigators in planning and establishing targets for accrual, while requiring this component as a part of annual protocol review and monitoring of accrual, offers a successful strategy that can be replicated in other cancer centers, an approach that may extend to other clinical and translational research centers.

Pathologic outcomes of nonmalignant papillary breast lesions diagnosed at imaging-guided core needle biopsy.

PURPOSE: To determine the upstage rate from nonmalignant papillary breast lesions obtained at imaging-guided core needle biopsy (CNB) and if there are any clinical, imaging, or pathologic features that can be used to predict eventual upstaging to malignancy. MATERIALS AND METHODS: This retrospective case review was institutional review board approved and HIPAA compliant, with a waiver of informed consent. A database search (from January 2001 to March 2010) was performed to find patients with a nonmalignant papillary breast lesion diagnosed at CNB. Of the resulting 128 patients, 86 (67%) underwent surgical excision; 42 (33%) patients were observed with imaging, for a median observation time of 4.1 years (range, 1.0-8.6 years). Chart review was performed to determine pertinent features of each case. RESULTS: Fourteen of 128 patients were subsequently found to have malignancy at excision, for an upstage rate of 11%. Nine (7%) of the 128 patients were subsequently found to have atypia at excision. Comparisons between patients with upstaged lesions and patients whose lesions were not upstaged demonstrated patients with upstaged lesions to be slightly older (65 vs 56 years, P=.01), more likely to have a mass than calcifications at imaging (P=.03), and to have had less tissue obtained at biopsy (three vs five cores obtained, P=.02; 14- vs 9-gauge needle used, P<.01; no vacuum assistance used, P<.01). Most strongly predictive of eventual malignancy, however, was whether the interpreting pathologist qualified the benign diagnosis at CNB with additional commentary (P<.01). CONCLUSION: Given the substantial upstage rate (11%) of papillary lesions diagnosed at imaging-guided CNB, surgical excision is an appropriate management decision; however, careful evaluation in concert with an expert breast pathologist may allow for observation in appropriately selected patients.

Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk.

CONTEXT: Annual ultrasound screening may detect small, node-negative breast cancers that are not seen on mammography. Magnetic resonance imaging (MRI) may reveal additional breast cancers missed by both mammography and ultrasound screening. OBJECTIVE: To determine supplemental cancer detection yield of ultrasound and MRI in women at elevated risk for breast cancer. DESIGN, SETTING, AND PARTICIPANTS: From April 2004-February 2006, 2809 women at 21 sites with elevated cancer risk and dense breasts consented to 3 annual independent screens with mammography and ultrasound in randomized order. After 3 rounds of both screenings, 612 of 703 women who chose to undergo an MRI had complete data. The reference standard was defined as a combination of pathology (biopsy results that showed in situ or infiltrating ductal carcinoma or infiltrating lobular carcinoma in the breast or axillary lymph nodes) and 12-month follow-up. MAIN OUTCOME MEASURES: Cancer detection rate (yield), sensitivity, specificity, positive predictive value (PPV3) of biopsies performed and interval cancer rate. RESULTS: A total of 2662 women underwent 7473 mammogram and ultrasound screenings, 110 of whom had 111 breast cancer events: 33 detected by mammography only, 32 by ultrasound only, 26 by both, and 9 by MRI after mammography plus ultrasound; 11 were not detected by any imaging screen. Among 4814 incidence screens in the second and third years combined, 75 women were diagnosed with cancer. Supplemental incidence-screening ultrasound identified 3.7 cancers per 1000 screens (95% CI, 2.1-5.8; P < .001). Sensitivity for mammography plus ultrasound was 0.76 (95% CI, 0.65-0.85); specificity, 0.84 (95% CI, 0.83-0.85); and PPV3, 0.16 (95% CI, 0.12-0.21). For mammography alone, sensitivity was 0.52 (95% CI, 0.40-0.64); specificity, 0.91 (95% CI, 0.90-0.92); and PPV3, 0.38 (95% CI, 0.28-0.49; P < .001 all comparisons). Of the MRI participants, 16 women (2.6%) had breast cancer diagnosed. The supplemental yield of MRI was 14.7 per 1000 (95% CI, 3.5-25.9; P = .004). Sensitivity for MRI and mammography plus ultrasound was 1.00 (95% CI, 0.79-1.00); specificity, 0.65 (95% CI, 0.61-0.69); and PPV3, 0.19 (95% CI, 0.11-0.29). For mammography and ultrasound, sensitivity was 0.44 (95% CI, 0.20-0.70, P = .004); specificity 0.84 (95% CI, 0.81-0.87; P < .001); and PPV3, 0.18 (95% CI, 0.08 to 0.34; P = .98). The number of screens needed to detect 1 cancer was 127 (95% CI, 99-167) for mammography; 234 (95% CI, 173-345) for supplemental ultrasound; and 68 (95% CI, 39-286) for MRI after negative mammography and ultrasound results. CONCLUSION: The addition of screening ultrasound or MRI to mammography in women at increased risk of breast cancer resulted in not only a higher cancer detection yield but also an increase in false-positive findings. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00072501.

Effect of transition to digital mammography on clinical outcomes.

PURPOSE: To determine the effect of transition to digital screening mammography on clinical outcome measures, including recall rate, cancer detection rate, and positive predictive value (PPV). MATERIALS AND METHODS: Institutional review board approval and the need for informed consent were waived for this HIPAA-complaint study. Practice audit data were obtained for three breast imaging radiologists from 2004 to 2009. These data were sorted by time period into the following groups: baseline (2004-2005), digital year 1 (2007), digital year 2 (2008), and digital year 3 (2009). The χ(2) and Fisher exact tests were used to assess differences in proportions among and between years. Clinical outcomes based on lesion type from 2004 to 2008 were also compared. Computer-aided detection was used. RESULTS: The three radiologists interpreted 32 600 screen-film mammograms and 33 879 digital mammograms. Recall rates increased from 6.0% at baseline to 7.1% in digital year 1 (P < .0001) and continued to increase in subsequent years to 8.5%. The cancer detection rate increased from 3.3 at baseline to 5.3 in digital year 1 (P = .0061), and it remained higher than that at baseline in subsequent years. PPV after screening mammogaphy (PPV(1)) increased from 5.6% at baseline to 7.5% in digital year 1 and returned to baseline levels in digital year 3. In contrast, PPV after biopsy (PPV(3)) decreased from 44.5% at baseline to 30.3% in digital year 3 (P = .0021). From 2004 to 2008, 3444 patients with 3493 lesions were recalled. The percentage of recalls for calcifications increased from 13.8% at baseline to a peak of 23.9% in digital year 1 and 17.9% in digital year 2. Both PPV(1) and PPV(3) decreased for calcifications after the digital transition. CONCLUSION: Recall rate and cancer detection rate increase for at least 2 years after the transition to digital screening mammography. PPV(3) is significantly reduced after digital transition, primarily in patients with microcalcifications.

Comparison of soft-copy and hard-copy reading for full-field digital mammography.

PURPOSE: To compare radiologists' performance in detecting breast cancer when reading full-field digital mammographic (FFDM) images either displayed on monitors or printed on film. MATERIALS AND METHODS: This study received investigational review board approval and was HIPAA compliant, with waiver of informed consent. A reader study was conducted in which 26 radiologists read screening FFDM images displayed on high-resolution monitors (soft-copy digital) and printed on film (hard-copy digital). Three hundred thirty-three cases were selected from the Digital Mammography Image Screening Trial screening study (n = 49,528). Of these, 117 were from patients who received a diagnosis of breast cancer within 15 months of undergoing screening mammography. The digital mammograms were displayed on mammographic workstations and printed on film according to the manufacturer's specifications. Readers read both hard-copy and soft-copy images 6 weeks apart. Each radiologist read a subset of the total images. Twenty-two readers were assigned to evaluate images from one of three FFDM systems, and four readers were assigned to evaluate images from two mammographic systems. Each radiologist assigned a malignancy score on the basis of overall impression by using a seven-point scale, where 1 = definitely not malignant and 7 = definitely malignant. RESULTS: There were no significant differences in the areas under the receiver operating characteristic curves (AUCs) for the primary comparison. The AUCs for soft-copy and hard-copy were 0.75 and 0.76, respectively (95% confidence interval: -0.04, 0.01; P = .36). Secondary analyses showed no significant differences in AUCs on the basis of manufacturer type, lesion type, or breast density. CONCLUSION: Soft-copy reading does not provide an advantage in the interpretation of digital mammograms. However, the display formats were not optimized and display software remains an evolving process, particularly for soft-copy reading.

Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer.

CONTEXT: Screening ultrasound may depict small, node-negative breast cancers not seen on mammography. OBJECTIVE: To compare the diagnostic yield, defined as the proportion of women with positive screen test results and positive reference standard, and performance of screening with ultrasound plus mammography vs mammography alone in women at elevated risk of breast cancer. DESIGN, SETTING, AND PARTICIPANTS: From April 2004 to February 2006, 2809 women, with at least heterogeneously dense breast tissue in at least 1 quadrant, were recruited from 21 sites to undergo mammographic and physician-performed ultrasonographic examinations in randomized order by a radiologist masked to the other examination results. Reference standard was defined as a combination of pathology and 12-month follow-up and was available for 2637 (96.8%) of the 2725 eligible participants. MAIN OUTCOME MEASURES: Diagnostic yield, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) of combined mammography plus ultrasound vs mammography alone and the positive predictive value of biopsy recommendations for mammography plus ultrasound vs mammography alone. RESULTS: Forty participants (41 breasts) were diagnosed with cancer: 8 suspicious on both ultrasound and mammography, 12 on ultrasound alone, 12 on mammography alone, and 8 participants (9 breasts) on neither. The diagnostic yield for mammography was 7.6 per 1000 women screened (20 of 2637) and increased to 11.8 per 1000 (31 of 2637) for combined mammography plus ultrasound; the supplemental yield was 4.2 per 1000 women screened (95% confidence interval [CI], 1.1-7.2 per 1000; P = .003 that supplemental yield is 0). The diagnostic accuracy for mammography was 0.78 (95% CI, 0.67-0.87) and increased to 0.91 (95% CI, 0.84-0.96) for mammography plus ultrasound (P = .003 that difference is 0). Of 12 supplemental cancers detected by ultrasound alone, 11 (92%) were invasive with a median size of 10 mm (range, 5-40 mm; mean [SE], 12.6 [3.0] mm) and 8 of the 9 lesions (89%) reported had negative nodes. The positive predictive value of biopsy recommendation after full diagnostic workup was 19 of 84 for mammography (22.6%; 95% CI, 14.2%-33%), 21 of 235 for ultrasound (8.9%, 95% CI, 5.6%-13.3%), and 31 of 276 for combined mammography plus ultrasound (11.2%; 95% CI. 7.8%-15.6%). CONCLUSIONS: Adding a single screening ultrasound to mammography will yield an additional 1.1 to 7.2 cancers per 1000 high-risk women, but it will also substantially increase the number of false positives. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00072501.

Screening mammography practice essentials.

A successful screening mammography practice has three directives. The first directive is quality mammography interpretation, which results in detection of a high percentage of early stage breast cancers, an acceptable recall rate, and an acceptable biopsy rate and yield. The second directive is providing a cost-efficient service. The third directive is access for as many eligible women as possible. Strategies that have helped improve screening mammography access for underserved women are discussed in this article.

A survey of breast imaging fellowship programs: current status of curriculum and training in the United States and Canada.

PURPOSE: The Society of Breast Imaging and the Education Committee of the ACR Breast Commission conducted a survey of breast imaging fellowship programs to determine the status of fellowship curricula, help identify strengths and potential areas for improvement, and assess the current demand for fellowship programs. METHODS: In 2012, a two-part survey was emailed to breast imaging fellowship directors from 72 fellowship programs. RESULTS: Of the 66 respondents, a total of 115 positions were identified. There were 90 positions with 9-12 months of breast imaging, and 25 positions with 6 months focused on breast imaging. Approximately two-thirds of programs reported an increase in the number of fellowship applicants, with three-quarters having 3 or more applicants for each position. All programs offered digital mammography, breast MRI, and diagnostic ultrasound services, and nearly all provided experience with interventional procedures. Approximately one-third provided breast screening ultrasound training. More than two-thirds required at least a 1-day rotation with a breast surgeon. Important nonclinical areas of training were not addressed in many programs. Approximately 40% of programs did not offer training related to the practice audit, and one-third of programs did not provide formal training related to quality control. CONCLUSIONS: Breast imaging fellowships are currently in higher demand than in the past. Most fellowship programs provide training in the key imaging modalities and interventional procedures. Potential gaps in training for many programs include the practice audit, quality control procedures, breast positioning, and mammography technical factors.

The ACR/Society of Breast Imaging Resident and Fellowship Training Curriculum for Breast Imaging, updated.

The education committees of the ACR Commission on Breast Imaging and the Society of Breast Imaging have revised the resident and fellowship training curriculum to reflect the current state of breast imaging in the United States. The original curriculum, created by the Society of Breast Imaging in 2000, had been updated only once before, in 2006. Since that time, a number of significant changes have occurred in the way mammography is acquired, how adjunctive breast imaging methods are used, and how pathology is assessed. This curricular update is meant to reflect these and other changes and to offer guidance to educators and trainees in preparing those interested in providing breast imaging services.

Professional and economic factors affecting access to mammography: a crisis today, or tomorrow? Results from a national survey.

BACKGROUND: Objective data and anecdotal reports have suggested that access to mammography may be declining because of facility closures and difficulty in recruiting and retaining radiologists and radiologic technologists. To gain insight into the practice patterns, use of emerging technologies, and concerns of breast imagers in current practice, the Society of Breast Imaging (SBI) conducted a national survey of breast imaging practices in the U.S. METHODS: Between October 2003 and April 2004, the SBI conducted a survey of the SBI membership database, and received completed surveys from 575 breast imaging practices in the U.S. Responses to the survey regarding practice characteristics, the utilization of standard and emerging technologies, staffing, malpractice, finance, and morale were analyzed. RESULTS: Job vacancies for radiologists who read mammograms were reported in 163 practices (29%), 59 of which (10%) had 2 or more openings. A higher proportion of practices with job openings had long appointment waiting times for asymptomatic women when compared with fully staffed practices. Unfilled fellowship positions also were common, with 41 of 65 practices that offer fellowships reporting 47 openings. Among 554 responding practices, 55% reported that someone in their practice was sued because of a mammography related case within the past 5 years, and 50% of practices reported that the threat of lawsuits made radiologist staffing "moderately" or "a lot" more difficult. Of 521 responding practices, 35% reported financial losses in 2002. One in 5 respondents reported that they would prefer to spend less time in mammography, and fewer than 1 in 3 would recommend a breast imaging fellowship to a relative or friend. Emerging technologies, such as breast magnetic resonance imaging and screening ultrasound, currently are being performed in many practices. CONCLUSIONS: The survey results provide support for anecdotal reports that breast imaging practices face significant challenges and stresses, including shortages of key personnel, a lack of trainees, malpractice concerns, financial constraints, increased workload due to emerging technologies, low appeal of breast imaging as a career specialty, and the steady rise in the population of women of screening age.

Survey of radiology residents: breast imaging training and attitudes.

PURPOSE: To investigate the training and attitudes of residents regarding breast imaging. MATERIALS AND METHODS: A telephone survey was conducted with 201 4th-year residents (postgraduate medical school year 5) and 10 3rd-year residents (postgraduate medical school year 4) at 211 accredited radiology residencies in the United States and Canada. Survey topics included organization of the breast imaging section, residents' role in the section, clinical practice protocols of the training institution, residents' personal thoughts about breast imaging, and their interest in performing breast imaging in the future. RESULTS: Of 211 programs, 203 (96%) had dedicated breast imaging rotations; 196 (93%) rotations were 8 weeks or longer; 153 (73%), 12 weeks or longer. Residents dictated reports in 199 (94%) programs. Residents performed real-time ultrasonography (US) in 186 (88%) programs, needle localization in 199 (94%), US-guided biopsy in 174 (82%), and stereotactically guided biopsy in 181 (86%). One hundred eighty-four (87%) residents rated interpretation of mammograms more stressful than they did that of other images, and 137 (65%) believed mammograms should be interpreted by subspecialists. One hundred thirty-five (64%) residents would not consider a fellowship in breast imaging if offered, and 133 (63%) would not want to spend 25% or more of their time in clinical practice on interpretation of mammograms. The most common reasons given for not considering a fellowship or interpretation of mammograms were that breast imaging was not an interesting field, that they feared lawsuits, and that it was too stressful. Fellowships were offered at 53 programs, and at 46 programs, a total of 63 fellows were recruited. CONCLUSION: Residency training in breast imaging has improved in terms of time and curriculum. However, a majority of the residents would not consider a fellowship and did not want to interpret mammograms in their future practices.