Pressure-based Compression Guidance of the Breast in Digital Breast Tomosynthesis Using Flexible Paddles Compared to Conventional Compression.

OBJECTIVE: We investigated the effect of introducing a pressure-based flexible paddle on compression parameters and user and patient experience of digital breast tomosynthesis (DBT) combined with patient-assisted compression or technologist compression. METHODS: After institutional review board approval, women with a DBT appointment who gave informed consent received pressure-based flexible paddle breast compression. Eight lights on the paddle were illuminated (1.9 kPa per light) as pressure was applied, aiming for an 8-13.9 kPa target range. The compression level was applied by the technologist or the participant utilizing a remote control device. The participant's and technologist's experiences were assessed by a questionnaire. Compression parameters were compared to previous examinations. Comparative statistics were performed using t-tests. RESULTS: Pressure-based compression (PBC) was judged to be similar or more comfortable compared with previous traditional exams (80%, 83/103), and 87% (90/103) of participants would recommend PBC to friends. Pressure variability decreased for craniocaudal (CC) views (-55%, P < 0.001) and mediolateral oblique (MLO) views (-34%, P < 0.0001). Subgroup analysis showed a similar glandular dose for CC views, while breast thickness was reduced (-3.74 mm, P < 0.0001). For MLO views, both glandular dose (-0.13 mGy, P < 0.0001) and breast thickness were reduced (-6.70 mm, P < 0.0001). Mean compression parameters were similar for technologist compression and patient-assisted examinations. CONCLUSION: Use of the pressure-based flexible paddle in DBT, with or without patient-assisted compression, improved participant and technologist experience and reduced compression pressure variability, mean breast thickness, and glandular dose.

Optoacoustic Breast Imaging: Imaging-Pathology Correlation of Optoacoustic Features in Benign and Malignant Breast Masses.

OBJECTIVE: Optoacoustic ultrasound breast imaging is a fused anatomic and functional modality that shows morphologic features, as well as hemoglobin amount and relative oxygenation within and around breast masses. The purpose of this study is to investigate the positive predictive value (PPV) of optoacoustic ultrasound features in benign and malignant masses. SUBJECTS AND METHODS: In this study, 92 masses assessed as BI-RADS category 3, 4, or 5 in 94 subjects were imaged with optoacoustic ultrasound. Each mass was scored by seven blinded independent readers according to three internal features in the tumor interior and two external features in its boundary zone and periphery. Mean and median optoacoustic ultrasound scores were compared with histologic findings for biopsied masses and nonbiopsied BI-RADS category 3 masses, which were considered benign if they were stable at 12-month follow-up. Statistical significance was analyzed using a two-sided Wilcoxon rank sum test with a 0.05 significance level. RESULTS: Mean and median optoacoustic ultrasound scores for all individual internal and external features, as well as summed scores, were higher for malignant masses than for benign masses (p < 0.0001). High external scores, indicating increased hemoglobin and deoxygenation and abnormal vessel morphologic features in the tumor boundary zone and periphery, better distinguished benign from malignant masses than did high internal scores reflecting increased hemoglobin and deoxygenation within the tumor interior. CONCLUSION: High optoacoustic ultrasound scores, particularly those based on external features in the boundary zone and periphery of breast masses, have high PPVs for malignancy and, conversely, low optoacoustic ultrasound scores have low PPV for malignancy. The functional component of optoacoustic ultrasound may help to overcome some of the limitations of morphologic overlap in the distinction of benign and malignant masses.

A Pivotal Study of Optoacoustic Imaging to Diagnose Benign and Malignant Breast Masses: A New Evaluation Tool for Radiologists.

Purpose To compare the diagnostic utility of an investigational optoacoustic imaging device that fuses laser optical imaging (OA) with grayscale ultrasonography (US) to grayscale US alone in differentiating benign and malignant breast masses. Materials and Methods This prospective, 16-site study of 2105 women (study period: 12/21/2012 to 9/9/2015) compared Breast Imaging Reporting and Data System (BI-RADS) categories assigned by seven blinded independent readers to benign and malignant breast masses using OA/US versus US alone. BI-RADS 3, 4, or 5 masses assessed at diagnostic US with biopsy-proven histologic findings and BI-RADS 3 masses stable at 12 months were eligible. Independent readers reviewed US images obtained with the OA/US device, assigned a probability of malignancy (POM) and BI-RADS category, and locked results. The same independent readers then reviewed OA/US images, scored OA features, and assigned OA/US POM and a BI-RADS category. Specificity and sensitivity were calculated for US and OA/US. Benign and malignant mass upgrade and downgrade rates, positive and negative predictive values, and positive and negative likelihood ratios were compared. Results Of 2105 consented subjects with 2191 masses, 100 subjects (103 masses) were analyzed separately as a training population and excluded. An additional 202 subjects (210 masses) were excluded due to technical failures or incomplete imaging, 72 subjects (78 masses) due to protocol deviations, and 41 subjects (43 masses) due to high-risk histologic results. Of 1690 subjects with 1757 masses (1079 [61.4%] benign and 678 [38.6%] malignant masses), OA/US downgraded 40.8% (3078/7535) of benign mass reads, with a specificity of 43.0% (3242/7538, 99% confidence interval [CI]: 40.4%, 45.7%) for OA/US versus 28.1% (2120/7543, 99% CI: 25.8%, 30.5%) for the internal US of the OA/US device. OA/US exceeded US in specificity by 14.9% (P < .0001; 99% CI: 12.9, 16.9%). Sensitivity for biopsied malignant masses was 96.0% (4553/4745, 99% CI: 94.5%, 97.0%) for OA/US and 98.6% (4680/4746, 99% CI: 97.8%, 99.1%) for US (P < .0001). The negative likelihood ratio of 0.094 for OA/US indicates a negative examination can reduce a maximum US-assigned pretest probability of 17.8% (low BI-RADS 4B) to a posttest probability of 2% (BI-RADS 3). Conclusion OA/US increases the specificity of breast mass assessment compared with the device internal grayscale US alone. Online supplemental material is available for this article. © RSNA, 2017.

Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: the SomoInsight Study.

PURPOSE: To determine improvement in breast cancer detection by using supplemental three-dimensional (3D) automated breast (AB) ultrasonography (US) with screening mammography versus screening mammography alone in asymptomatic women with dense breasts. MATERIALS AND METHODS: Institutional review board approval and written informed consent were obtained for this HIPAA-compliant study. The SomoInsight Study was an observational, multicenter study conducted between 2009 and 2011. A total of 15 318 women (mean age, 53.3 years ± 10 [standard deviation]; range, 25-94 years) presenting for screening mammography alone with heterogeneously (50%-75%) or extremely (>75%) dense breasts were included, regardless of further risk characterization, and were followed up for 1 year. Participants underwent screening mammography alone followed by an AB US examination; results were interpreted sequentially. McNemar test was used to assess differences in cancer detection. RESULTS: Breast cancer was diagnosed at screening in 112 women: 82 with screening mammography and an additional 30 with AB US. Addition of AB US to screening mammography yielded an additional 1.9 detected cancers per 1000 women screened (95% confidence interval [CI]: 1.2, 2.7; P < .001). Of cancers detected with screening mammography, 62.2% (51 of 82) were invasive versus 93.3% (28 of 30) of additional cancers detected with AB US (P = .001). Of the 82 cancers detected with either screening mammography alone or the combined read, 17 were detected with screening mammography alone. Of these, 64.7% (11 of 17) were ductal carcinoma in situ versus 6.7% (two of 30) of cancers detected with AB US alone. Sensitivity for the combined read increased by 26.7% (95% CI: 18.3%, 35.1%); the increase in the recall rate per 1000 women screened was 284.9 (95% CI: 278.0, 292.2; P < .001). CONCLUSION: Addition of AB US to screening mammography in a generalizable cohort of women with dense breasts increased the cancer detection yield of clinically important cancers, but it also increased the number of false-positive results.

Detection of breast cancer with full-field digital mammography and computer-aided detection.

OBJECTIVE: The purpose of this study was to evaluate computer-aided detection (CAD) performance with full-field digital mammography (FFDM). MATERIALS AND METHODS: CAD (Second Look, version 7.2) was used to evaluate 123 cases of breast cancer detected with FFDM (Senographe DS). Retrospectively, CAD sensitivity was assessed using breast density, mammographic presentation, histopathology results, and lesion size. To determine the case-based false-positive rate, patients with four standard views per case were included in the study group. Eighteen unilateral mammography examinations with nonstandard views were excluded, resulting in a sample of 105 bilateral cases. RESULTS: CAD detected 115 (94%) of 123 cancer cases: six of six (100%) in fatty breasts, 63 of 66 (95%) in breasts containing scattered fibroglandular densities, 43 of 46 (93%) in heterogeneously dense breasts, and three of five (60%) in extremely dense breasts. CAD detected 93% (41/44) of cancers manifesting as calcifications, 92% (57/62) as masses, and 100% (17/17) as mixed masses and calcifications. CAD detected 94% of the invasive ductal carcinomas (n = 63), 100% of the invasive lobular carcinomas (n = 7), 91% of the other invasive carcinomas (n = 11), and 93% of the ductal carcinomas in situ (n = 42). CAD sensitivity for cancers 1-10 mm (n = 55) was 89%; 11-20 mm (n = 37), 97%; 21-30 mm (n = 16), 100%; and larger than 30 mm (n = 15), 93%. The CAD false-positive rate was 2.3 marks per four-image case. CONCLUSION: CAD with FFDM showed a high sensitivity in identifying cancers manifesting as calcifications and masses. Sensitivity was maintained in cancers with lower mammographic sensitivity, including invasive lobular carcinomas and small neoplasms (1-20 mm). CAD with FFDM should be effective in assisting radiologists with earlier detection of breast cancer. Future studies are needed to assess CAD accuracy in larger populations.

Assessment of suspected breast cancer by MRI: a prospective clinical trial using a combined kinetic and morphologic analysis.

OBJECTIVE: The objective of our study was to assess the incremental value of contrast-enhanced MRI in the diagnosis and treatment planning using both a three-time point kinetic and morphologic analysis in addition to mammography and sonography in patients thought to have early-stage breast cancer. SUBJECTS AND METHODS: Contrast-enhanced bilateral breast MRI was performed prospectively on 65 patients with highly suspicious imaging findings (BI-RADS category 4 or 5). All enrolled patients were believed to be candidates for breast conservation on the basis of clinical examination, mammography, and sonography. The primary index lesion's characteristics, size, and extent were assessed. Also, additional lesions detected by MRI that could represent potential malignancies in both the ipsilateral and contralateral breast were evaluated. Morphologic assessment and kinetic analysis were performed on each lesion using dedicated postprocessing and display software. The patients were reevaluated as to whether they were still candidates for breast-conservation therapy after the MRI examination and subsequent biopsies. RESULTS: There were 46 patients (71%) whose primary breast lesion (detected by mammography, sonography, or both) was found to be malignant (39 invasive breast cancers, five intraductal cancers, and two lymphomas). For the primary index lesions, the sensitivity for MRI was 100% (44/44) for predicting a breast malignancy and the specificity was 73.7% (14/19) for predicting benign lesions. MRI detected an additional 37 lesions, of which 23 were cancerous, beyond those suspected on mammography or sonography. One or more additional ipsilateral breast cancers were detected in 32% (14/44) of breast cancer patients and contralateral breast cancers in 9% (4/44) of the breast cancer patients. MRI also resulted in an incremental recommendation of mastectomy in 18% (8/44) of the pathologically confirmed breast cancer patients. MRI resulted in additional biopsy of only 14 benign lesions, six of which were shown to be atypical ductal hyperplasia. CONCLUSION: When added to the standard evaluation of clinical examination, mammography, and sonography in patients thought to have early-stage breast cancer, contrast-enhanced MRI using both a kinetic and morphologic analysis will often result in changes in recommended patient management and better treatment planning and will result in no significant increase in biopsies of benign lesions. In addition, there is a significant detection rate of occult contralateral breast cancers.