Breast Ultrasound Screening Research Articles

Reassessment and Follow-Up Results of BI-RADS Category 3 Lesions Detected on Screening Breast Ultrasound.

The purpose of this study is to determine the frequency and the malignancy rate of BI-RADS category 3 lesions detected on screening breast ultrasound and to reassess whether they satisfied the requirements of the American College of Radiology Imaging Network (ACRIN) 6666 protocol. Of 28,796 asymptomatic women who underwent screening mammography during 2 years, 12,187 underwent additional ultrasound as part of the screening. Patients for whom BI-RADS category 3 lesions were seen on the ultrasound were selected. We reviewed the initial ultrasound showing BI-RADS category 3 lesions and mammograms. We also investigated the clinical outcome of these lesions using the reference standard of a combination of pathologic analysis and follow-up for at least 24 months. The frequency of BI-RADS category 3 lesions detected on screening ultrasound was 14.6% (1783/12,187). Of the 1164 patients with a follow-up duration of at least 24 months or whose lesions were biopsied, eight were eventually proven to have malignancy (0.7%). The malignancy rate was 2.2% (4/184) for patients with abnormal mammograms and 0.4% (4/980) for those with normal mammograms. When the ACRIN 6666 protocols were strictly applied, 225 (19.3%) lesions were retrospectively recategorized as BI-RADS category 4 (n = 12) or category 2 (n = 213). All detected malignancies were early breast cancers with no lymph node metastasis. Although the frequency of ultrasound BI-RADS category 3 lesions is considerably high (14.6%), the malignancy rate is very low (0.7%), especially in patients with a normal mammogram. Therefore, with BI-RADS category 3 assessment, careful evaluation is required to avoid unnecessary short-interval follow-up or biopsy.

Undiagnosed Breast Cancer: Features at Supplemental Screening US

To retrospectively investigate the reasons for and features of undiagnosed cancers at previous supplemental screening ultrasonography (US) in women who subsequently received a diagnosis of breast cancer. The institutional review board approved this retrospective study and waived the requirement to obtain informed patient consent. The study consisted of 230 women (median age, 49 years; age range, 29-81 years) with 230 pairs of US examinations (prior and subsequent examinations) performed between December 2003 and August 2013 who were found to have cancer (median interval, 12 months; range, 2-24 months). The authors compared the clinical-pathologic features of patients with negative findings on prior images with those of patients with visible findings on prior images. Findings visible at prior US were classified as actionable or underthreshold by means of a blinded review by five radiologists. Lesions classified as Breast Imaging Reporting and Data System category 4 or 5 by fewer than three readers were determined to be underthreshold. Reasons for undiagnosed cancers and their imaging features were analyzed. Among the 230 prior US examinations, 72 (31.3%) showed visible findings and 158 (68.7%) showed negative findings. High-nuclear-grade cancers and triple-negative cancers were more common in patients with negative findings than in those with visible findings (P = .023 and P = .006, respectively). Blinded review revealed that 57 of the 72 visible findings (79%) were actionable. Misinterpretation (39% [28 of 72 lesions]) and multiple distracting lesions (17% [12 of 72 lesions]) were the two most common reasons for missing these actionable findings, which showed more noncircumscribed margins than did underthreshold findings (P = .028). At supplemental screening breast US, close attention should be paid to the presence of a margin that is not circumscribed, and multiple lesions should be separately assessed to reduce the number of missed breast cancers.

Multiple Bilateral Circumscribed Masses at Screening Breast US: Consider Annual Follow-up

To determine prospectively the prevalence and rate of malignancy of multiple bilateral (MB) circumscribed breast masses detected at screening ultrasonography (US) compared with those of other US-depicted masses. This institutional review board-approved, HIPAA-compliant prospective trial included women at elevated risk for breast cancer, who gave written informed consent to participate in a study evaluating cancer detection rates for three rounds of annual supplemental screening US at 21 international sites. After exclusions, 2662 participants and 7473 screening studies were included. Physician-performed US studies were interpreted, with blinding to mammography results. Simple cysts were noted. Breast Imaging Reporting and Data System features of all other findings were recorded, with addition of the descriptor MB similar-appearing circumscribed masses (minimum of three total and at least one in each breast), with details of the largest such mass recorded. Rates of malignancy were determined after biopsy or mammographic and US follow-up at a minimum of 11 months. For this analysis, 490 women (1370 screenings) with prior mastectomy were excluded. Descriptive statistics and exact 95% confidence intervals (CIs) were generated. Of 2172 evaluable participants (6103 screening studies; median age at study entry, 54.0 years; range, 25-91 years), 1454 had unique findings at US. One hundred thirty-five (6.2%) participants had 153 unique MB circumscribed masses, with no malignancies (0% [95% CI: 0%, 2.4%]; 95% CI: 0%, 2.9% for the 127 masses with at least 2 years of follow-up). There were 1319 (60.7%) participants with 2464 non-MB lesions, including 1038 solitary circumscribed masses with a malignancy rate of 0.8% (eight of 1038). Of 836 solitary circumscribed masses with at least 2 years of follow-up, the malignancy rate was 0.4% (three of 836; 95% CI: 0.1%, 1.0%). Of the 135 women with MB circumscribed masses, 82 (60.7%) also had a solitary lesion. Two of these 82 women (2.4%) had cancer. MB similar-appearing circumscribed masses seen at screening US are almost always benign, with no malignancies found among such lesions in this prospective, multicenter experience. These lesions are suitable for diagnostic follow-up in 1 year, with resumption of screening thereafter if they are stable.

Differences in Pain Perceptions between Automated Breast Ultrasound and Digital Screening Mammography

A prospective single-site survey was performed to gauge perceived pain during automated breast ultrasound (ABUS) and digital x-ray mammography (XRM). Patients also described differences in duration of the exams, provided their bra size, and indicated whether they would recommend ABUS to a friend. Pain was measured on a Likert-type visual analog scale (1–10). Participants were 199 female volunteers who also participated in the prospective, multicenter, nationwide clinical research study SOMO•INSIGHT. There was a mean pain and/or discomfort score of 6.41 (± 2.41) for XRM and a mean score of 1.86 (± 1.24) for ABUS ( P = .001). Bra size and perceived examination duration played no role in determining patient pain and/or discomfort. One hundred percent of patients who participated said that they would recommend ABUS to a friend. These data suggest that if ABUS is proven to be a valuable adjunctive screening test for breast cancer among women with dense breast tissue, its routine use will be well tolerated by patients.

Supplementary Breast Ultrasound Screening in Asian Women with Negative But Dense Mammograms—A Pilot Study

Dense breasts are common in Asian women and they limit the sensitivity of mammography. This study evaluates the performance of supplementary breast ultrasound screening in Asian women with dense mammograms. The study was approved by the hospital's Institutional Review Board. A prospective clinical trial was performed between September 2002 and November 2004. Asymptomatic Asian women with negative and dense mammograms were offered supplementary ultrasound screening for breast cancer. Ultrasound assessment was categorised as U1 to U4. U1 and U2 cases were recommended routine interval screening mammography. U3 cases were recommended follow-up ultrasound in 6 months and routine interval screening mammography and U4 cases were recommended biopsy. One hundred and forty-one women with mean age of 45.1 years were enrolled into the study. Mean scan time was 13.0 minutes (± 5.6 minutes) for bilateral vs 11.0 minutes (± 1.4 minutes) for unilateral scans. There were 10 patients and 14 patients in the in the U3 and U4 categories, respectively. Two U4 category patients were diagnosed with malignancy-a-6 mm ductal carcinoma-in-situ and a 13- mm invasive ductal carcinoma. The breast cancer detection rate was 1.4%. Sensitivity and specifi city were 100% (2/2) and 88.5% (92/104) respectively. The positive predictive value was 14.3% (2/14) and the negative predictive value was 100% (92/92). This pilot study reveals the usefulness of supplementary ultrasound screening in detecting early stage mammographically and clinically occult breast cancers in Asian women with dense breasts. A larger long-term study is, however, needed to assess its feasibility and impact on breast cancer prognosis.

The Connecticut Experiment: The Role of Ultrasound in the Screening of Women With Dense Breasts

The aim of this study was to determine the potential of screening breast ultrasound to improve breast cancer detection in women with mammographically normal, but dense breasts. Six Connecticut radiology practices with 12 total sites participated in a retrospective chart review. The total number of screening mammograms, screening ultrasounds broken down by BIRADS (Breast Imaging Reporting and Data System) codes, and the number of positive and negative biopsies were collected from November 2009 through November 2010. Demographic data on the patients with positive biopsies as well as cancer staging were also collected. Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value were calculated. A total of 72,030 screening mammograms and 8,647 screening ultrasounds were performed at the research sites during the study period. Relevant research indicates that 41% of the female population has dense breasts. In this study, 12% (8,647/72,030) underwent follow-up breast ultrasound screening. A total of 86% (7,451/8,647) of the ultrasounds were BIRADS 1 or 2, 9% (767/8,647) were BIRADS 3, 5% (429/8,647) were BIRADS 4 or 5. Of those 429 recommended to undergo biopsy 418 were performed and 28 cancers were found. There was one false negative. Screening breast ultrasound in women with mammographically normal, but dense breasts has a Positive Predictive Value (PPV) of 6.7% (28/418), Negative Predictive Value (NPV) of 99.9% (7,450/7,451), sensitivity of 96.6% (28/29), and a specificity of 94.9% (7,450/7,851). Screening ultrasound had an additional yield of 3.25 per 1,000 cancers in women with dense breasts and normal mammograms and no additional risk factors. As with all screening tests, time, cost, and false positive risk must be considered.

Other Methods of Axillary Assessment and Their Value

The purpose of our study was to assess the cancer detection rate and positive predictive value (PPV) for incidentally detected abnormal axillary lymph nodes with negative mammography and subsequent breast ultrasound (US). We included 7039 screened patients (mean age, 52 y) from January 2012 to March 2015 with negative mammography and subsequent breast US results. In two patients with positive lymph nodes, neither were from breast malignancy. The calculated cancer detection rate, PPV for biopsy and axillary biopsy rate was 0.3 per 1000 axillary US, 14.3% and 0.2%. Cancer rates for patients with a family or personal operation history, with cancer history and with no family/operation/cancer history were 0%, 0.1% and 0.2%, respectively. Our results indicate that the cancer detection rate and PPV for US were too low to recommend routine axillary scanning including screening breast US in patients with negative mammography and subsequent breast US, especially with no history of any cancers.

Screening US in Patients with Mammographically Dense Breasts: Initial Experience with Connecticut Public Act 09-41

To determine performance and utilization of screening breast ultrasonography (US) in women with dense breast tissue who underwent additional screening breast US in the 1st year since implementation of Connecticut Public Act 09-41 requiring radiologists to inform patients with heterogeneous or extremely dense breasts at mammography that they may benefit from such examination. Informed consent was waived for this institutional review board-approved, HIPAA-compliant retrospective review of 935 women with dense breasts at mammography who subsequently underwent handheld screening and whole-breast US from October 1, 2009, through September 30, 2010. Of 935 women, 614 (65.7%) were at low risk, 149 (15.9%) were at intermediate risk, and 87 (9.3%) were at high risk for breast cancer. Of the screening breast US examinations, in 701 (75.0%), results were classified as Breast Imaging Reporting and Data System (BI-RADS) category 1 or 2; in 187 (20.0%), results were classified as BI-RADS category 3; and in 47 (5.0%), results were classified as BI-RADS category 4. Of 63 aspirations or biopsies recommended and performed in 53 patients, in nine, lesions were BI-RADS category 3, and in 54, lesions were BI-RADS category 4. Among 63 biopsies and aspirations, three lesions were malignant (all BI-RADS category 4, diagnosed with biopsy). All three cancers were smaller than 1 cm, were found in postmenopausal patients, and were solid masses. One cancer was found in each risk group. In 44 of 935 (4.7%) patients, examination results were false-positive. Overall positive predictive value (PPV) for biopsy or aspirations performed in patients with BI-RADS category 4 masses was 6.5% (three of 46; 95% confidence interval [CI]: 1.7%, 19%). Overall cancer detection rate was 3.2 cancers per 1000 women screened (three of 935; 95% CI: 0.8 cancers per 1000 women screened, 10 cancers per 1000 women screened). Technologist-performed handheld screening breast US offered to women in the general population with dense breasts can aid detection of small mammographically occult breast cancers (cancer detection rate, 0.8-10 cancers per 1000 women screened), although the overall PPV is low.

0679: How to Reduce False Positive Rates in Breast Ultrasound Screening

0679: How to Reduce False Positive Rates in Breast Ultrasound Screening

Establishment of seminars to improve the diagnostic accuracy and effectiveness of breast ultrasound.

To improve the ability of technicians and physicians to find and diagnose breast lesions in breast ultrasound screening. Seminars were organized for technicians and physicians engaged in breast ultrasound screening, and tests were carried out to evaluate the usefulness of the seminars. Each seminar lasted 2 days and comprised lectures and group activities. Pretests and post-tests conducted before and after each seminar, respectively, consisted of 100 questions: 50 about animated images, and 50 about static images. The tests required the participant to find lesions in animated images and estimate the probability of malignancy from static images. In the animated image tests, sensitivity was greater after the seminar, although specificity did not change significantly. In the static image tests, sensitivity increased, and a significant increase was also observed in the receiver operating curve analysis for degree of certainty in diagnosing cancer. The seminars improved the participants' ability to find and diagnose breast lesions during ultrasound screening.

Operator Dependence of Physician-performed Whole-Breast US: Lesion Detection and Characterization

To prospectively examine operator dependence of lesion detection, description, and interpretation when experienced breast radiologists perform whole-breast ultrasonography (US). Institutional review board approval was obtained for the HIPAA-compliant study. Ten women (aged 19-53 years; mean, 37.4 years; 20 breasts) with numerous known breast lesions consented to participate. Eleven breast radiologists, who passed experience and qualification requirements for a screening breast US trial and consented to participate, scanned both breasts in all participants and documented images of each detected lesion and its size, location, features, palpability, and Breast Imaging Reporting and Data System final assessment. Intraclass correlation coefficients (ICCs) were used to measure agreement on lesion size and location, and kappa statistics were calculated for agreement on features and final assessments compared with consensus. Eighty-eight unique lesions were identified by at least two investigators (five to 13 lesions per participant). Mean diameter was 6.7 mm (standard error, 0.4; range, 2-22 mm), and eight lesions (9%) were palpable. Of 968 potential detections (88 lesions, 11 investigators), 536 (55%) detections were made. Individual investigators detected between 43 (49%) and 58 (66%) lesions. Larger lesions were more consistently detected: Detection rates were six of 33 lesions (18%) at 3 mm or smaller; 164 of 374 (43.9%) at 3.1-5 mm; 145 of 275 (52.7%) at 5.1-7 mm; 119 of 176 (67.6%) at 7.1-9 mm; 38 of 44 (86%) at 9.1-11 mm; and 64 of 66 (97%) lesions larger than 11 mm (P < .001). ICCs for clockface, distance from nipple, and individual lesion diameter all exceeded 0.7, indicating high reliability. For shape, margins, and final assessments of solid lesions, kappa values were 0.62, 0.67 (substantial agreement), and 0.52 (moderate agreement), respectively. Of 110 detections of consensus cysts 8 mm and smaller, 15 (14%) detections were considered to be of solid lesions by at least one reader. Larger lesions (>11 mm) are most consistently detected, with fewer than half of lesions 5 mm or smaller in mean diameter identified; substantial agreement was found for description of lesion size, location, and key features, and moderate agreement was found for lesion management.

Anthropomorphic Breast Phantoms for Qualification of Investigators for ACRIN Protocol 6666

The purpose of this study was to evaluate various ultrasonic properties of breast phantoms developed for use in qualifying investigators for participation in the American College of Radiology Imaging Network (ACRIN) protocol 6666, "Screening Breast Ultrasound in High-Risk Women." Specifically, a tool was sought to consistently measure the performance of radiology personnel in detecting and characterizing lesions similar to those expected with screening breast ultrasonography (US). The phantoms are equivalent to one another except for the randomization of positions of 14 of the 17 simulated lesions. The lesions differ in depth and ultrasonic properties. Representative values of propagation speed, attenuation, relative echogenicity, and mass density are reported for all tissue-mimicking components. Beam refraction occurs at the interface between the subcutaneous fat layer and the glandular parenchyma and can result in beam distortion artifacts similar to those encountered in clinical breast US.

Breast Ultrasound in Women With Familial Risk of Breast Cancer

Introduction: The aim of this study was to assess the performance and value of breast ultrasound in women with familial risk of breast cancer. Materials and Methods: From an initial dataset of 245 women with positive family history who had breast cancer surveillance utilising mammography or magnetic resonance imaging (MRI) between November 1994 and February 2001, 179 subjects with follow-up data were selected. Eighty-four women had breast ultrasound done with histopathological correlation available from 48 breast biopsies performed in 42 women. Results: The sensitivity of ultrasound, mammography and MRI was 83.3%, 53.9% and 93.3%, respectively. The specificity of ultrasound, mammography and MRI was 65.5%, 85.7% and 63.6%, respectively. Ultrasound was the imaging modality with intermediate sensitivity, specificity, negative predictive value (NPV) and cancer detection rate. The sensitivity, specificity, positive predictive value (PPV), NPV and accuracy of combined mammography and ultrasound were 92.9%, 62.5%, 52.0%, 95.2% and 71.7%, respectively. These results did not differ significantly from MRI. Almost two-thirds of the breast biopsies were performed under ultrasound guidance. Conclusion: Although breast ultrasound screening per se was not assessed in this study, extrapolation of these results to sonographic screening of high familial risk women would come at a better specificity to MRI, albeit with a 10% decrease in sensitivity but at a fraction of the cost of MRI. Ultrasound also provides the advantage of convenient imaging guidance for biopsy. Employing ultrasound following mammography would match MRI in sensitivity, specificity, PPV, NPV and accuracy, and should not be ignored in these women.

Rationale for a trial of screening breast ultrasound: American College of Radiology Imaging Network (ACRIN) 6666.

Rationale for a Trial of Screening Breast Ultrasound: American College of Radiology Imaging Network (ACRIN) 6666Wendie A. Berg1Audio Available | Share