A risk model for digital breast tomosynthesis to predict breast cancer and guide clinical care.

Screening with digital breast tomosynthesis (DBT) improves breast cancer detection and reduces false positives. However, currently, no breast cancer risk model takes advantage of the additional information generated by DBT imaging for breast cancer risk prediction. We developed and internally validated a DBT-based short-term risk model for predicting future late-stage and interval breast cancers after negative screening exams. We included the available 805 incident breast cancers and a random sample of 5173 healthy women matched on year of study entry in a nested case-control study from 154,200 multiethnic women, aged 35 to 74, attending DBT screening in the United States between 2014 and 2019. A relative risk model was trained using elastic net logistic regression and nested cross-validation to estimate risks for using imaging features and age. An absolute risk model was developed using derived risks and U.S. incidence and competing mortality rates. Absolute risks, discrimination performance, and risk stratification were estimated in the left-out validation set. The discrimination performance of 1-year risk was 0.82 (95% CI, 0.79 to 0.85) with good calibration (P = 0.7). Using the U.S. Preventive Service Task Force guidelines, 14% of the women were at high risk, 19.6 times higher compared to general risk. In this high-risk group, 76% of stage II and III cancers and 59% of stage 0 cancers were observed (P < 0.01). Using mammographic features generated from DBT screens, our image-based risk prediction model could guide radiologists in selecting women for clinical care, potentially leading to earlier detection and improved prognoses.

Case of second primary breast cancer in ectopic breast tissue and review of the literature.

Accessory breast tissue (ABT) is found in approximately 2%-6% of the female population and are subject to most of the physiological and pathological changes that occur in pectoral breast. Primary breast cancer occurring in ABT is a rare occurrence and a second primary breast cancer occurring in an accessory breast has never been reported. We report the case of a 60-year-old woman with a history of mastectomy for left breast cancer 5 years prior to presentation, who presented with an enlarging right axilla mass found to be a second primary breast cancer in an accessory tissue on biopsy. Many physicians are unfamiliar with the clinical presentation of accessory breast cancer due to the rarity of the condition and this ultimately results in delayed diagnosis and advanced disease at presentation. It is therefore prudent that physicians have a high index of suspicion when patients present with axillary masses.

Imaging characteristics of metaplastic breast cancer with osteoblastic differentiation.

An 82-year-old female presented to her breast surgeon with a hard, painful mass in the left breast. Mammography demonstrated a new hyperdense mass with pleomorphic calcifications of trabeculated appearance. Ultrasound-guided biopsy demonstrated a hypoechoic mass with significantly increased vascularity and tissue stiffness as well as additional irregular, hypoechoic masses in the same area. Together these findings suggested multifocal malignancy. The pathology report from the biopsy demonstrated fragments of solid sheets of epithelioid and focally spindled cells with multinucleated osteoclast giant cells. This was found to be most consistent with metaplastic carcinoma showing osteoblastic differentiation. The patient received a left-sided mastectomy. During follow-up with the patient, adjuvant chemotherapy was not advised given the relatively unknown survival advantage in this elderly patient.

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.

The Association of Mammography Environment and Image Quality.

OBJECTIVE: This study sought to determine if a mammogram performed in a multi-sensory environmental upgraded room (UR) is associated with improved image quality when compared to a standard room (SR). METHODS: A retrospective analysis (interrupted time series design) of compression force and posterior nipple line (PNL) measurements was performed on 303 women (mean age 60.9 years) who underwent screening mammography for 2 consecutive years (year 1 in SR, year 2 in UR) at a single outpatient facility. Using the Picture Archiving Communication System (PACS), craniocaudal (CC) and mediolateral oblique (MLO) images for the two years were reviewed. The PNL was measured for the CC and MLO images bilaterally using the embedded tools in the PACS software. Posterior nipple line and compression force were analyzed using a paired t-test. Bland-Altman plots were used to obtain 95% limits of agreement (LOA) between the UR and SR. RESULTS: Image quality as determined by PNL measurement distance was greater in the UR (P < 0.001) when compared with the SR, with similar compression force (P ≥ 0.14). Mean PNL measurement differences ranged from 5.0 to 6.2 mm greater in the UR, whereas mean compression force differences ranged from -2.4 to 1.5 newtons. The 95% LOA suggest that PNL measurement differences between the UR and SR can vary by -11.0 to 27.0 mm. CONCLUSION: Environmentally modifying mammography rooms may improve image quality with regard to PNL measurements without increasing compression force.

Detection of Breast Cancer with Mammography: Effect of an Artificial Intelligence Support System.

Purpose To compare breast cancer detection performance of radiologists reading mammographic examinations unaided versus supported by an artificial intelligence (AI) system. Materials and Methods An enriched retrospective, fully crossed, multireader, multicase, HIPAA-compliant study was performed. Screening digital mammographic examinations from 240 women (median age, 62 years; range, 39-89 years) performed between 2013 and 2017 were included. The 240 examinations (100 showing cancers, 40 leading to false-positive recalls, 100 normal) were interpreted by 14 Mammography Quality Standards Act-qualified radiologists, once with and once without AI support. The readers provided a Breast Imaging Reporting and Data System score and probability of malignancy. AI support provided radiologists with interactive decision support (clicking on a breast region yields a local cancer likelihood score), traditional lesion markers for computer-detected abnormalities, and an examination-based cancer likelihood score. The area under the receiver operating characteristic curve (AUC), specificity and sensitivity, and reading time were compared between conditions by using mixed-models analysis dof variance and generalized linear models for multiple repeated measurements. Results On average, the AUC was higher with AI support than with unaided reading (0.89 vs 0.87, respectively; P = .002). Sensitivity increased with AI support (86% [86 of 100] vs 83% [83 of 100]; P = .046), whereas specificity trended toward improvement (79% [111 of 140]) vs 77% [108 of 140]; P = .06). Reading time per case was similar (unaided, 146 seconds; supported by AI, 149 seconds; P = .15). The AUC with the AI system alone was similar to the average AUC of the radiologists (0.89 vs 0.87). Conclusion Radiologists improved their cancer detection at mammography when using an artificial intelligence system for support, without requiring additional reading time. Published under a CC BY 4.0 license. See also the editorial by Bahl in this issue.

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.

Breast cancer detection using high-resolution breast PET compared to whole-body PET or PET/CT.

PURPOSE: To compare the performance characteristics of positron emission mammography (PEM) with those of whole-body PET (WBPET) and PET/CT in women with newly diagnosed breast cancer. METHODS: A total of 178 women consented to PEM for presurgical planning in an IRB-approved protocol and also underwent either WBPET (n = 69) or PET/CT (n = 109) imaging, as per usual care at three centers. Tumor detection sensitivity, positive predictive values, and (18)F-fluorodeoxyglucose (FDG) uptake were compared between the modalities. The effects of tumor size, type, and grade on detection were examined. The chi-squared or Fisher's exact tests were used to compare distributions between groups, and McNemar's test was used to compare distributions for paired data within subject groups, i.e. PEM versus WBPET or PEM versus PET/CT. RESULTS: The mean age of the women was 59 ± 12 years (median 60 years, range 26-89 years), with a mean invasive index tumor size of 1.6 ± 0.8 cm (median 1.5 cm, range 0.5-4.0 cm). PEM detected more index tumors (61/66, 92%) than WBPET (37/66, 56%; p < 0.001) or PET/CT (95/109, 87% vs. 104/109, 95% for PEM; p < 0.029). Sensitivity for the detection of additional ipsilateral malignancies was also greater with PEM (7/15, 47%) than with WBPET (1/15, 6.7%; p = 0.014) or PET/CT (3/23, 13% vs. 13/23, 57% for PEM; p = 0.003). Index tumor detection decreased with decreasing invasive tumor size for both WBPET (p = 0.002) and PET/CT (p < 0.001); PEM was not significantly affected (p = 0.20). FDG uptake, quantified in terms of maximum PEM uptake value, was lowest in ductal carcinoma in situ (median 1.5, range 0.7-3.0) and invasive lobular carcinoma (median 1.5, range 0.7-3.4), and highest in grade III invasive ductal carcinoma (median 3.1, range 1.4-12.9). CONCLUSION: PEM was more sensitive than either WBPET or PET/CT in showing index and additional ipsilateral breast tumors and remained highly sensitive for tumors smaller than 1 cm.

Comparative effectiveness of positron emission mammography and MRI in the contralateral breast of women with newly diagnosed breast cancer.

OBJECTIVE: The objective of our study was to compare the performance of positron emission mammography (PEM) with that of MRI in the evaluation of the contralateral breast of women with newly diagnosed cancer. SUBJECTS AND METHODS: Four hundred seventy-two women with newly diagnosed breast cancer offered breast-conserving surgery from September 2006 through November 2008 consented to participate in a multicenter protocol. Participants underwent contrast-enhanced breast MRI and 18F-FDG PEM in randomized order, and the examinations were interpreted independently. The performance characteristics of the imaging modalities were compared using the McNemar test and generalized estimating equations. A retrospective blinded review of PEM images was performed by four experienced observers to understand the reasons for false-negatives. RESULTS: Three hundred sixty-seven women (median age, 58 years; age range, 26-93 years) eligible for analysis completed the appropriate follow-up for study inclusion. Fifteen women (4.1%) were found to have contralateral cancer (11 invasive [mean tumor size, 12 mm; median, 10 mm; range, 1-22 mm] and four ductal carcinoma in situ). Of the 15 cases, both PEM and MRI showed three (20%), only MRI showed 11 (73%), and one (6.7%) was found at prophylactic mastectomy. MRI sensitivity at 14 of 15 (93%; 95% CI, 66-94) was higher than PEM at three of 15 (20%; 95% CI, 5.3-46) (p<0.001). On PEM, three additional cancers were seen prospectively but were considered probably benign and two other cancers were visible in retrospect at the site. Of 352 contralateral breasts without cancer, findings were negative or benign on PEM for 335 (95.2%; 95% CI, 92.2-97.0), which is more than MRI at 315 (89.5%; 95% CI, 85.7-92.4; p=0.002). The positive predictive value (PPV) of PEM-prompted biopsies (3/14 [21%]) was not significantly different from the PPV of MRI (15/54 [28%], p=0.58). On blinded retrospective PEM review of the 15 contralateral cancers, PEM findings for 11 (73%) were considered suspicious. CONCLUSION: Contralateral cancer was found in 15 of 367 women (4.1%), with MRI showing 14 (93%). Eleven contralateral cancers (73%) were visible on PEM, but only three (20%) were recognized prospectively as suspicious. Lesions that are visible on PEM should be viewed as suspicious unless known to be benign by prior breast imaging or biopsy.

PET-guided breast biopsy.

Molecular imaging, using positron emission tomography (PET), has become an integral step in the evaluation of many patients with malignancy. However, its use in patients with breast cancer has been limited by the lower levels of (18) F-fluorodeoxyglucose (FDG) uptake in some breast malignancies compared to other cancers, the small size of many breast cancers, and the need for biopsy under PET guidance. High-resolution breast PET, or positron emission mammography (PEM), with biopsy guidance software, now addresses these issues. We report a prospective, multicenter study designed to test the efficacy and safety of PEM biopsy guidance software in women with FDG-avid breast lesions worrisome for malignancy. The intervention chosen was vacuum-assisted core biopsy. Nineteen subjects underwent a total of 24 PEM-guided biopsies. All lesions were successfully targeted and sampled as determined by post-biopsy image scan evaluation, specimen imaging, and pathologic concordance. Invasive cancer was identified in 13 of 24 lesions (54%), while four (17%) were high-risk lesions and three of these were upgraded to malignancy at excision. No serious adverse events occurred and all patients found the procedure to cause only minimal to mild discomfort. High-resolution PEM-guided breast biopsy is both safe and effective for the sampling of PET-depicted breast lesions.

Breast cancer: comparative effectiveness of positron emission mammography and MR imaging in presurgical planning for the ipsilateral breast.

PURPOSE: To determine the performance of positron emission mammography (PEM), as compared with magnetic resonance (MR) imaging, including the effect on surgical management, in ipsilateral breasts with cancer. MATERIALS AND METHODS: Four hundred seventy-two women with newly diagnosed breast cancer who were offered breast-conserving surgery consented from September 2006 to November 2008 to participate in a multicenter institutional review board-approved, HIPAA-compliant protocol. Participants underwent contrast material-enhanced MR imaging and fluorine 18 fluorodeoxyglucose PEM in randomized order; resultant images were interpreted independently. Added biopsies and changes in surgical procedure for the ipsilateral breast were correlated with histopathologic findings. Performance characteristics were compared by using the McNemar test and generalized estimating equations. RESULTS: Three hundred eighty-eight women (median age, 58 years; age range, 26-93 years; median estimated tumor size, 1.5 cm) completed the study. Additional cancers were found in 82 (21%) women (82 ipsilateral breasts; median tumor size, 0.7 cm). Twenty-eight (34%) of the 82 breasts were identified with both PEM and MR imaging; 21 (26%) breasts, with MR imaging only; 14 (17%) breasts, with PEM only; and seven (8.5%) breasts, with mammography and ultrasonography. Twelve (15%) cases of additional cancer were missed at all imaging examinations. Integration of PEM and MR imaging increased cancer detection-to 61 (74%) of 82 breasts versus 49 (60%) of 82 breasts identified with MR imaging alone (P < .001). Of 306 breasts without additional cancer, 279 (91.2%) were correctly assessed with PEM compared with 264 (86.3%) that were correctly assessed with MR imaging (P = .03). The positive predictive value of biopsy prompted by PEM findings (47 [66%] of 71 cases) was higher than that of biopsy prompted by MR findings (61 [53%] of 116 cases) (P = .016). Of 116 additional cancers, 61 (53%) were depicted by MR imaging and 47 (41%) were depicted by PEM (P = .043). Fifty-six (14%) of the 388 women required mastectomy: 40 (71%) of these women were identified with MR imaging, and 20 (36%) were identified with PEM (P < .001). Eleven (2.8%) women underwent unnecessary mastectomy, which was prompted by only MR findings in five women, by only PEM findings in one, and by PEM and MR findings in five. Thirty-three (8.5%) women required wider excision: 24 (73%) of these women were identified with MR imaging, and 22 (67%) were identified with PEM. CONCLUSION: PEM and MR imaging had comparable breast-level sensitivity, although MR imaging had greater lesion-level sensitivity and more accurately depicted the need for mastectomy. PEM had greater specificity at the breast and lesion levels. Eighty-nine (23%) participants required more extensive surgery: 61 (69%) of these women were identified with MR imaging, and 41 (46%) were identified with PEM (P = .003). Fourteen (3.6%) women had tumors seen only at PEM.

Positron emission mammography in breast cancer presurgical planning: comparisons with magnetic resonance imaging.

PURPOSE: The objective of this study was to compare the performance characteristics of (18)F-fluorodeoxyglucose (FDG) positron emission mammography (PEM) with breast magnetic resonance imaging (MRI) as a presurgical imaging and planning option for index and ipsilateral lesions in patients with newly diagnosed, biopsy-proven breast cancer. METHODS: Two hundred and eight women >25 years of age (median age = 59.7 ± 14.1 years) with biopsy-proven primary breast cancer enrolled in this prospective, single-site study. MRI, PEM, and whole-body positron emission tomography (WBPET) were conducted on each patient within 7 business days. PEM and WBPET images were acquired on the same day after intravenous administration of 370 MBq of FDG (median = 432.9 MBq). PEM and MRI images were blindly evaluated, compared with final surgical histopathology, and the sensitivity determined. Substudy analysis compared the sensitivity of PEM versus MRI in patients with different menopausal status, breast density, and use of hormone replacement therapy (HRT) as well as determination of performance characteristics for additional ipsilateral lesion detection. RESULTS: Two hundred and eight patients enrolled in the study of which 87% (182/208) were analyzable. Of these analyzable patients, 26.4% (48/182), 7.1% (13/182), and 64.2% (120/182) were pre-, peri-, and postmenopausal, respectively, and 48.4% (88/182) had extremely or heterogeneously dense breast tissue, while 33.5% (61/182) had a history of HRT use. Ninety-two percent (167/182) underwent core biopsy for index lesion diagnosis. Invasive cancer was found in 77.5% (141/182), while ductal carcinoma in situ (DCIS) and/or Paget's disease were found in 22.5% (41/182) of patients. Both PEM and MRI had index lesion depiction sensitivity of 92.8% and both were significantly better than WBPET (67.9%, p < 0.001, McNemar's test). For index lesions, PEM and MRI had equivalent sensitivity of various tumors, categorized by tumor stage as well as similar invasive tumor size predictions with Spearman's correlation coefficient of 0.61 for both PEM and MRI compared to surgical pathology. Menopausal status, breast density, and HRT did not influence the sensitivity of PEM or MRI. For 67 additional unsuspected ipsilateral lesions or multifocal lesions, PEM had sensitivity of 85% (34/40) and specificity of 74%, (20/27) compared to MRI's sensitivity of 98% (39/40) and specificity of 48% (13/27) [p = 0.074, for sensitivity; p = 0.096 for specificity] CONCLUSION: PEM is a good alternative to MRI as a presurgical breast imaging option and its performance characteristics are not affected by patient menopausal/hormonal status or breast density.

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.

Multicenter evaluation of the breast lesion excision system, a percutaneous, vacuum-assisted, intact-specimen breast biopsy device.

BACKGROUND: Percutaneous, vacuum-assisted, large-gauge core needle biopsy (VACNB) provides an alternative to open surgical biopsy as an initial diagnostic tool for breast lesions, yet rates of underestimating malignant diagnoses remain sufficiently high to warrant surgical biopsy in some cases. The current study was performed to determine if the Breast Lesion Excision System (BLES) provides a feasible alternative to VACNB. METHODS: A retrospective review was conducted of 742 consecutive mammographic lesions with microcalcifications classified as Breast Imaging Reporting and Data System (BIRADS) IV or V that had stereotactic percutaneous biopsy using BLES. Initial diagnoses obtained from the histopathologic examination of tissues retrieved at biopsy were compared with the histopathologic examination of tissues received from surgical excision or lumpectomy. Underestimation rates for atypical ductal hyperplasia (ADH) and ductal carcinoma in situ (DCIS) were recorded if open surgical biopsy revealed DCIS or invasive cancer, and invasive cancer, respectively. RESULTS: Of the 742 breast lesions, 34 displayed ADH upon biopsy with the BLES device. Two patients did not receive open surgical biopsy. Of the 32 patients who had open surgical excision, 3 (9.4%) had DCIS or invasive cancer. There were 119 diagnoses of DCIS upon biopsy with the BLES device. Four patients did not receive open surgical biopsy. Of the 115 patients who had open surgical excision, 6 (5.2%) had invasive cancer. CONCLUSIONS: Breast biopsy can be performed accurately using the BLES device. Compared with VACNB, it does not alter the need for surgical excision in women diagnosed with ADH or DCIS at core biopsy.

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.

HEAL: an instructional design model applied to an online clerkship in family medicine.

OBJECTIVE: The potential of distance learning technology to deliver educational programs in which instruction and evaluation are of a consistent and high standard across multiple settings is hampered by a lack of instructional design models. In response, we developed the HEAL (Heuristic for Electronic Asynchronous Learning) model for designing online curricula. DESCRIPTION: HEAL is based on the theories that learning is facilitated by independent problem solving, investigation, and discovery (heuristics); collaboration between students fosters learning; and the proven educational cycle of practice, feedback, and reflection is integral to the interrelated domains of skill development and personal awareness.(1) The HEAL model is defined by synergistic online learning activities integrated with real patient care. It is applicable to all medical education levels. We applied this innovative design template to an online curriculum that augments our conventional six-week third-year clerkship. Our students, who were placed in distant family physician offices, needed more interaction and learning from peers and faculty. The three elements of HEAL, and implementation in the "online clerkship," are: (1) Didactic modules teach and illustrate concepts. Students study modules (HTML pages) on management of diabetes (DM), and complete five modules on evidence-based medicine (EBM). They do EBM literature searches reviewed online by peers, faculty, and librarians, who provide feedback. (2) A problem-based case discussion promotes application of concepts from modules (horizontal curricular integration). Students view streamed video of a patient with a history suggestive of diabetes, review her medical chart online, and suggest evidence-based management in an asynchronous discussion group. The case progresses weekly to mimic 12 months of continuity of care. (3) A collaborative journal activity explores the results of applying elements one and two to real patients (vertical integration). Additional elements advance reflection, professionalism, and medical humanism. Participation in the journal discussion group, stimulated by online readings, enhances self-awareness, informs psychosocial aspects of element 2, and promotes generalization of learning objectives to real patients. We use BlackBoard software. Students log in two to three times per week. Faculty who are trained in online moderation facilitate the threaded discussion groups and provide feedback. DISCUSSION: Students in alternating clerkship blocks complete the online clerkship. Their performance is compared with that of students who complete a face-to-face diabetes curriculum, but no curriculum on EBM or medical humanism. After nearly a year (105 students), compared with the non-online group, students completing the online clerkship demonstrated greater gains in reported EBM skills from preto post-clerkship, larger increases in mean score (from pre to post) on a medical-humanism aptitude scale, and higher scores on a post-clerkship diabetes management assessment (all comparisons p <.05). The online clerkship will become a permanent part of our clerkship and we have begun to use HEAL to design other online courses, including continuing education courses.