Preoperative Differentiation of HER2-Zero and HER2-Low from HER2-Positive Invasive Ductal Breast Cancers Using BI-RADS MRI Features and Machine Learning Modeling.

BACKGROUND: Accurate determination of human epidermal growth factor receptor 2 (HER2) is important for choosing optimal HER2 targeting treatment strategies. HER2-low is currently considered HER2-negative, but patients may be eligible to receive new anti-HER2 drug conjugates. PURPOSE: To use breast MRI BI-RADS features for classifying three HER2 levels, first to distinguish HER2-zero from HER2-low/positive (Task-1), and then to distinguish HER2-low from HER2-positive (Task-2). STUDY TYPE: Retrospective. POPULATION: 621 invasive ductal cancer, 245 HER2-zero, 191 HER2-low, and 185 HER2-positive. For Task-1, 488 cases for training and 133 for testing. For Task-2, 294 cases for training and 82 for testing. FIELD STRENGTH/SEQUENCE: 3.0 T; 3D T1-weighted DCE, short time inversion recovery T2, and single-shot EPI DWI. ASSESSMENT: Pathological information and BI-RADS features were compared. Random Forest was used to select MRI features, and then four machine learning (ML) algorithms: decision tree (DT), support vector machine (SVM), k-nearest neighbors (k-NN), and artificial neural nets (ANN), were applied to build models. STATISTICAL TESTS: Chi-square test, one-way analysis of variance, and Kruskal-Wallis test were performed. The P values <0.05 were considered statistically significant. For ML models, the generated probability was used to construct the ROC curves. RESULTS: Peritumoral edema, the presence of multiple lesions and non-mass enhancement (NME) showed significant differences. For distinguishing HER2-zero from non-zero (low + positive), multiple lesions, edema, margin, and tumor size were selected, and the k-NN model achieved the highest AUC of 0.86 in the training set and 0.79 in the testing set. For differentiating HER2-low from HER2-positive, multiple lesions, edema, and margin were selected, and the DT model achieved the highest AUC of 0.79 in the training set and 0.69 in the testing set. DATA CONCLUSION: BI-RADS features read by radiologists from preoperative MRI can be analyzed using more sophisticated feature selection and ML algorithms to build models for the classification of HER2 status and identify HER2-low. TECHNICAL EFFICACY: Stage 2.

Added Value of the Vascular Index on Superb Microvascular Imaging for the Evaluation of Breast Masses: Comparison With Grayscale Ultrasound.

OBJECTIVES: To evaluate the value of the vascular index (VI) on Superb Microvascular Imaging (SMI; Canon Medical Systems Corporation, Tokyo, Japan) in comparison with grayscale ultrasound (US) alone for assessing breast masses. METHODS: We evaluated a total of 70 breast masses (36 malignant and 34 benign lesions) in 70 consecutive patients using grayscale US and SMI. Two breast radiologists analyzed grayscale US alone and the combination of grayscale US and SMI. They also measured the VI based on SMI. The diagnostic performance of grayscale US alone and the combination of grayscale US and SMI was compared. The VI was compared between benign and malignant masses, and the optimal cutoff value was determined. In addition, the interobserver agreement in imaging analyses and the VI was assessed. RESULTS: The interobserver agreements in imaging analyses and the VI were almost perfect. The VI of malignant breast masses was significantly higher than that of benign lesions (P < .001). The optimal cutoff value of the VI for differentiating between malignant and benign breast masses was 2.95, with sensitivity of 86.1% and specificity of 91.2%. The diagnostic performance values of grayscale US alone and the combination of grayscale US and SMI were 0.824 and 0.912, respectively, for reader 1 (P = .028) and 0.795 and 0.853 for reader 2 (P = .101). CONCLUSIONS: The VI on SMI was significantly higher for malignant breast masses than for benign lesions, with high interobserver agreement. Our study suggests that the combination of grayscale US and SMI with the VI could improve the characterization of breast masses.

Surgical Outcomes for Ductal Carcinoma in Situ: Impact of Preoperative MRI.

Background The role of preoperative MRI for predicting surgical outcomes in patients diagnosed with ductal carcinoma in situ (DCIS) remains uncertain. Purpose To investigate the associations between preoperative MRI and surgical outcomes in DCIS confirmed by using US-guided core-needle biopsy (CNB) and to evaluate clinical-pathologic variables associated with a benefit from MRI. Materials and Methods Women with DCIS confirmed by using US-guided CNB between January 2012 and December 2016 were included in this retrospective study. Propensity score matching using 18 confounding covariates was used to create matched groups with MRI and without MRI, and surgical outcomes were compared. Clinical-pathologic variables were evaluated to determine women who benefited from MRI. Results A total of 541 women (mean age ± standard deviation, 50 years ± 10) were evaluated. Among 430 women who underwent MRI, 67 additional lesions (16%) were depicted, with 25 (37%) of the 67 additional lesions being malignant. Fifty-seven (13%) of the 430 women had a change in surgical plan because of their MRI findings; the change was appropriate for 31 (54%) women. In matched groups, the MRI group was associated with lower odds of positive resection margin (odds ratio [OR], 0.39; 95% confidence interval [CI]: 0.16, 0.93; P = .03) and repeat surgery (OR, 0.33; 95% CI: 0.12, 0.92; P = .03) compared with the non-MRI group. There was no difference in likelihood of initial mastectomy (OR, 1.2; 95% CI: 0.7, 2.0; P = .59) and overall mastectomy (OR, 0.93; 95% CI: 0.5, 1.6; P = .79). In the MRI group, low nuclear grade (90% [28 of 31] vs 69% [275 of 399]; P = .01), progesterone receptor positivity (81% [25 of 31] vs 61% [244 of 399]; P = .03), and human epidermal growth factor receptor 2 negativity (90% [28 of 31] vs 68% [270 of 399]; P = .01) were associated with a benefit from MRI versus no MRI. Conclusion Preoperative MRI depicted additional malignancy and reduced positive surgical margins and repeat surgery for ductal carcinoma in situ confirmed at US-guided biopsy without a higher mastectomy rate. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Pinker in this issue.

The role of MRI and clinicopathologic features in predicting the invasive component of biopsy-confirmed ductal carcinoma in situ.

BACKGROUND: The upgrade rate of biopsy-confirmed ductal carcinoma in situ (DCIS) to invasive carcinoma is up to 50% on final pathology. We investigated MRI and clinicopathologic predictors of the invasive components of DCIS diagnosed by preoperative biopsy and then compared MRI features between patients with DCIS, microinvasive ductal carcinoma (mIDC), and invasive ductal carcinoma (IDC) diagnosed on final pathology. METHODS: Two hundred and one patients with 206 biopsy-confirmed DCIS lesions were enrolled. MRI and clinicopathologic features were used to predict either mIDC or IDC via a cumulative logistic regression analysis. For the lesions detected on MRI, morphologic and kinetic analyses were performed using the Chi-square, Fisher's exact, and Kruskal-Wallis tests. RESULTS: Of all the lesions, 112 (54.4%) were diagnosed as DCIS, 50 (24.3%) were upgraded to mIDC, and 44 (21.4%) to IDC. The detection on MRI as mass (Odds ratio (OR) = 8.84, 95% confidence interval (CI) = 1.05-74.04, P = 0.045) or non-mass enhancement (NME; OR = 11.17, 95% CI = 1.35-92.36, P = 0.025), negative progesterone receptor (PR; OR = 2.40, 95% CI = 1.29-4.44, P = 0.006), and high Ki-67 level (OR = 2.42, 95% CI = 1.30-4.50, P = 0.005) were significant independent predictors of histologic upgrade. On MRI, 87 (42.2%) lesions appeared as mass and 107 (51.9%) as NME. Irregularly shaped, not-circumscribed, heterogeneous, or rim-enhancing masses with intratumoral high signal intensity or peritumoral edema, clumped or clustered ring-enhancing NMEs, and high peak enhancement were significantly associated with histologic upgrade (P < 0.001). CONCLUSION: MRI detection, negative PR, and high Ki-67 levels are associated with a histologic upgrade in patients with biopsy-confirmed DCIS. Suspicious MRI features are more frequent in such patients.

Diffusion-weighted imaging with reverse phase-encoding polarity: the added value to the conventional diffusion-weighted imaging in differentiating acute infarctions from hyperintense brainstem artifacts.

OBJECTIVES: The aim of our study was to assess the value of diffusion-weighted imaging with reverse phase-encoding polarity (R-DWI) in addition to conventional DWI using forward phase-encoding polarity (F-DWI) in differentiating acute brainstem infarctions from hyperintense artefacts. METHODS: Seventy-six patients with 38 hyperintense brainstem artefacts and 38 acute brainstem infarctions that had undergone F-DWI and R-DWI were retrospectively selected based on the clinicoradiological diagnosis. Four radiologists independently rated their confidence in diagnosing acute infarctions and ruling out brainstem artefacts in a blind manner, and then compared the diagnostic performance and confidence between F-DWI alone and F-DWI with R-DWI. RESULTS: The areas under the curve determined for F-DWI with R-DWI in diagnosing infarctions were significantly higher than F-DWI alone for all readers (resident 1, 0.908 vs 0.776; resident 2, 0.908 vs 0.789; neuroradiologist, 0.961 vs 0.868; emergency radiologist, 0.934 vs 0.855, all p < 0.05). All readers were more confident using F-DWI with R-DWI than F-DWI alone (all p < 0.05) for diagnosing acute brainstem infarction, and three readers (readers except the neuroradiologist) were more confident using F-DWI with R-DWI for ruling out brainstem artefacts (p ≤ 0.001). CONCLUSION: The addition of R-DWI to F-DWI is a valuable method for differentiating acute brainstem infarctions from hyperintense artefacts. KEY POINTS: • Hyperintense brainstem artefacts can be confused with acute infarctions on DWI. • Additional R-DWI to F-DWI reduces inter-reader variability in diagnosing brainstem infarctions. • Additional R-DWI improves performance and confidence for discriminating infarctions from artefacts.

Association between loneliness and cognitive function, and brain volume in community-dwelling elderly.

Introduction: We investigated the relationship between loneliness, cognitive impairment, and regional brain volume among elderly individuals residing in the Korean community. Methods: Data from the ARIRANG aging-cognition sub-cohort, collected between 2020 and 2022, were utilized for the present study. Loneliness was assessed using the UCLA-Loneliness Scale (UCLA-LS) questionnaire and the relevant item from Center for Epidemiologic Studies Depression Scale Korean version (CES-D-K). Cognitive impairment was measured through Mini-Mental State Examination (K-MMSE-2) and Seoul Neuropsychological Screening Battery (SNSB-C), with five sub-categories: attention, memory, visuospatial function, language, and executive function. Logistic regression was employed for prevalence ratios related to cognitive impairment, while linear regression was used for regional brain volume including white matter hyperintensity (WMH) and cortical thickness. Results: Our analysis involved 785 participants (292 men and 493 women). We observed increased cognitive impairment assessed by K-MMSE-2 [UCLA-LS: odds ratio (OR) 3.133, 95% confidence interval (CI) 1.536-6.393; loneliness from CES-D: OR 2.823, 95% CI 1.426-5.590] and SNSB-C total score (UCLA-LS: OR 2.145, 95% CI 1.304-3.529) in the lonely group compared to the non-lonely group. Specifically, the lonely group identified by UCLA-LS showed an association with declined visuospatial (OR 1.591, 95% CI 1.029-2.460) and executive function (OR 1.971, 95% CI 1.036-3.750). The lonely group identified by CES-D-K was associated with impaired memory (OR 1.577, 95% CI 1.009-2.466) and executive function (OR 1.863, 95% CI 1.036-3.350). In the regional brain volume analysis, loneliness was linked to reduced brain volume in frontal white matter (left: -1.24, 95% CI -2.37 ∼-0.12; right: -1.16, 95% CI -2.31 ∼ -0.00), putamen (left: -0.07, 95% CI -0.12 ∼-0.02; right: -0.06, 95% CI -0.11 ∼-0.01), and globus pallidus (-15.53, 95% CI -30.13 ∼-0.93). There was no observed association in WMH and cortical thickness. Conclusion: Loneliness is associated with cognitive decline and volumetric reduction in the frontal white matter, putamen, and globus pallidus.

Outcomes and imaging features of microinvasive carcinoma and ductal carcinoma in situ: Matched cohort study.

INTRODUCTION: The purpose of this study is to investigate the differences in clinical outcomes between microinvasive carcinoma (mIC) and ductal carcinoma in situ (DCIS) and compare the imaging features of both using mammography, US and MRI. MATERIALS AND METHODS: This retrospective study was approved by our institutional review board. Between January 2011 and December 2013, 516 women with mIC or DCIS confirmed by surgery were included. Patients were matched with propensity score matching to compare recurrence-free survival (RFS). RFS was compared using a Cox proportional hazards model. Imaging features were also compared between the two groups. RESULTS: Among 516 women, 219 mIC and 297 DCIS tumors were identified. After matching, 132 women were allocated to each group. The mean follow-up duration was 80.2 months. In the matched cohort, no statistically significant association was observed between the DCIS and mIC groups in terms of total recurrence (hazard ratio [HR]: 1.7; 95% confidence interval [CI]: 0.8-4.0; P = 0.19), local-regional recurrence (HR: 3.4; 95% CI: 0.9-12.3, P = 0.07), or contralateral recurrence (HR: 0.9; 95% CI: 0.3-2.8, P = 0.89). Non-mass lesions at US (P = 0.004), moderate or marked background parenchymal enhancement (P = 0.04), and higher peak enhancement (P = 0.02) at MRI were more commonly seen in the mIC group than in the DCIS group. CONCLUSION: Microinvasive carcinomas are distinct from DCIS in terms of imaging features, but no statistically significant association in recurrence survival.

Epipericardial Fat Necrosis in a Pediatric Patient Diagnosed Using Contrast-Enhanced MRI Findings: A Case Report and Literature Review.

Epipericardial fat necrosis (EPFN) is a relatively rare cause of acute chest pain, with only five pediatric cases having been reported in the English-language medical literature to date. EPFN can be diagnosed based on the clinical symptoms of acute pleuritic chest pain and classic CT features of typically ovoid fatty lesions surrounded by a rim or capsule in the mediastinal or pericardial areas. Previous studies have reported that contrast-enhanced MRI can detect typical fat signal changes in adults with EPFN. We report a pediatric EPFN case diagnosed using gadolinium-enhanced MRI. Thus, contrast-enhanced MRI may be used to confirm EPFN in the differential diagnoses of the causes of acute chest pain.

Comparison of the Imaging Features of Lobular Carcinoma In Situ and Invasive Lobular Carcinoma of the Breast.

Purpose: To investigate the usefulness of imaging features for differentiating between small lobular carcinoma in situ (LCIS) and invasive lobular carcinoma (ILC). Materials and Methods: It included 52 female with LCISs (median 45 years, range 32-67 years) and 180 female with ILCs (median 49 years, range 36-75 years), with the longest diameter of ≤ 2 cm, who were evaluated between January 2012 and December 2016. All the female underwent mammography and ultrasonography. Twenty female with LCIS and 150 female with ILC underwent MRI. The clinical and imaging features were compared, and multivariate analysis was performed to identify the independent predictors of LCIS. Female with LCIS were also subgrouped by lesion size and compared with the female with ILC. Results: Multivariate analysis showed that younger age [odds ratio (OR) = 1.100], smaller lesion size (OR = 1.103), oval or round shape (OR = 4.098), parallel orientation (OR = 5.464), and isoechotexture (OR = 3.360) were significant independent factors predictive of LCIS. The area under the receiver operating characteristic curve for distinguishing LCIS from ILC was 0.904 (95% confidence interval, 0.857-0.951). Subgroup analysis showed that benign features were more prevalent in female with smaller LCISs (≤ 1 cm) than in those with ILC. Conclusion: Small LCISs tend to demonstrate more benign features than small ILCs. Several imaging features are independently predictive of LCIS.

Clinicopathological and Imaging Features Predictive of Clinical Outcome in Metaplastic Breast Cancer.

BACKGROUND: Metaplastic breast cancer (MC) is a rare disease, thus it is difficult to study its clinical outcomes. OBJECTIVES: To investigate whether any clinicopathological or imaging features were associated with clinical outcome in MC. METHODS: We retrospectively evaluated the clinicopathological and imaging findings, and the clinical outcomes of seventy-two pathologically confirmed MCs. We then compared these parameters between triple-negative (TNMC) and non-TNMCs (NTNMC). RESULTS: Oval or round shape, and not-circumscribed margin were the most common findings on mammography, ultrasound (US), and magnetic resonance imaging (MRI). It was mostly a mass without calcification on mammography, and revealed complex or hypoechoic echotexture, and posterior acoustic enhancement on US, and rim enhancement, wash-out kinetics, peritumoral edema, and intratumoral necrosis on MRI. Of all 72, 64 were TNMCs, and eight were NTNMCs. Clinicopathological and imaging findings were similar between the two groups, except that MRI showed peritumoral edema more frequently in TNMCs than NTNMCs (p=0.045). There were 21 recurrences and 13 deaths. Multivariable analysis showed that larger tumor size and co-existing DCIS were significantly predictive of Disease free survival (DFS), and larger tumor size and neoadjuvant chemotherapy were significantly predictive of overall survival (OS). CONCLUSION: MC showed characteristic imaging findings, and some variables associated with survival outcome may help to predict prognosis.

Feasibility of supine MRI (Magnetic Resonance Imaging)-navigated ultrasound in breast cancer patients.

OBJECTIVE: The purpose of this study was to evaluate the feasibility of image fusion between US and supine MRI in breast cancer patients, and to evaluate differences in tumor location between prone and supine positions. METHODS: This prospective study included 88 patients who underwent an additional supine MRI (MRsup) sequence following routine prone MRI (MRpro) for breast cancer between May 2016 and December 2017. The location of the tumor and discrepancies in the distances from nipple to lesion (NLD), skin to lesion (SLD), and chest wall to lesion (CLD) were evaluated between MRpro and MRsup (MRpro-sup), MRpro and MRsup-navigated US (MRpro-USnav), and MRsup and USnav (MRsup-USnav). Associations between breast thickness and measurement discrepancies were analyzed. RESULTS: Total 91 index lesions were evaluated. The intraclass correlation coefficients (ICCs) for the location of MRpro and MRsup compared with USnav were 0.994 (range: 0.990-0.996) and 0.998 (range: 0.996-0.999), respectively. The mean MRpro-sup and MRpro-USnav measurement discrepancies were greater than those of MRsup-USnav, significantly. Most outer locations showed greater mean measurement discrepancies than inner locations, and each NLD, SLD, and CLD mean measurement discrepancy showed different tendencies according to location (upper or lower) and lesion depth (superficial, middle, or deep). High breast thickness showed significantly greater mean measurement discrepancies than low breast thickness. CONCLUSION: Image fusion between US and supine MRI is feasible in breast cancer patients, although there is a considerable difference in tumor location measurements between prone and supine positions, especially with thicker breasts.

Breast tumor movements analysis using MRI scans in prone and supine positions.

We quantitatively evaluated breast tumor movement and volume changes between magnetic resonance imaging (MRI) scans in prone and supine positions. Twenty-seven breast tumor patients who received neoadjuvant systemic therapy (NST) for breast-conserving surgery were studied. Before and after NST, MRI scans in prone and supine positions were performed immediately. Tumor segmentation, volume, and position of tumors were evaluated in both positions. Average tumor volumes in prone and supine positions did not significantly differ (p = 0.877). Tumor movement from prone to supine positions from the origin of the bottom center of the sternum was strongly correlated with the distance from the tumor center to the chest wall (r = 0.669; p < 0.05). Tumor changes from prone to supine positions measured from the origin of the nipple depended on the location of the tumor in the breast. The prone-to-supine movement of all tumors from the origin of the bottom center of the sternum tended to move outward from the sagittal centerline of the body on the coronal plane, to the inside of the body on the sagittal plane, and outward and downward close to the body on the axial plane, which might help in planning operations using prone MRI in supine-position breast cancer surgery.

Imaging and Clinicopathologic Features Associated With Pathologic Complete Response in HER2-positive Breast Cancer Receiving Neoadjuvant Chemotherapy With Dual HER2 Blockade.

BACKGROUND: In human epidermal growth factor receptor 2-positive (HER2+) breast cancer, the incorporation of a dual HER2 blockade into neoadjuvant chemotherapy (NAC) has been shown to induce a higher rate of pathologic complete response (pCR). The purpose of this study was to investigate whether pretreatment imaging and clinicopathologic features show any association with pCR in HER2+ breast cancer receiving NAC plus dual blockade. MATERIALS AND METHODS: This retrospective study evaluated 94 consecutive patients (mean age, 49.8 ± 9.9 years) with HER2+ breast cancer who underwent NAC plus dual blockade with trastuzumab and pertuzumab between April 2016 and June 2018. All patients underwent mammography, ultrasound, and magnetic resonance imaging prior to NAC. Clinicopathologic and imaging features acquired before NAC were evaluated for their ability to predict the pathologic response after surgery. Multivariate analysis was used to identify independent predictors of pCR. RESULTS: Fifty patients (53.2%) showed pCR and 44 (46.8%) did not. According to a univariate analysis, fine pleomorphic/fine linear or linear-branching calcification morphology on mammography, parallel orientation on ultrasound, intratumoral high signal intensity on T2-weighted magnetic resonance imaging, progesterone receptor negativity, and high levels of tumor-infiltrating lymphocytes were associated with pCR. On multivariate analysis, fine pleomorphic/fine linear or linear-branching calcification morphology on mammography (odds ratio [OR], 7.23), progesterone receptor negativity (OR, 6.76), and a high tumor-infiltrating lymphocyte level (OR, 5.92) remained significant independent factors associated with pCR. CONCLUSION: Several pretreatment imaging and clinicopathologic features were shown to be independent variables predicting pCR in patients with HER2+ breast cancer receiving NAC with dual blockade.

Complete response on MR imaging after neoadjuvant chemotherapy in breast cancer patients: Factors of radiologic-pathologic discordance.

PURPOSE: To evaluate the radiologic and clinicopathologic factors in radiologic-pathologic discordance (false-negative results) in breast cancer patients who demonstrate radiologic complete response (rCR) in MR imaging after neoadjuvant chemotherapy (NAC). METHOD: Our institutional review board approved this retrospective study. We included 209 consecutive patients who showed rCR in MR imaging after NAC. rCR was diagnosed when the original lesion site showed no enhancement. Pathologic CR (pCR) was defined as the complete absence of both invasive cancer and ductal carcinoma in situ in the breast upon pathology. Clinicopathologic and radiologic factors affecting the radiologic-pathologic correlation were analyzed. RESULTS: pCR was noted in 108 patients (51.7%); the remaining 101 (48.3%) had residual lesion on pathology. False negative rCR findings were significantly more frequent in cases of 1 or 2 histologic grade (p = 0.001), low tumor-infiltrating lymphocytes (p = 0.004), and luminal A or B subtype (p < 0.001). Multivariate analysis of radiologic findings to identify predictors of false negative findings found calcifications in mammography (p = 0.037), multifocal multicentric lesions (p = 0.004), and non-mass enhancement in pretreatment MR imaging (p = 0.023) to be significantly associated with false-negative findings. CONCLUSIONS: Patients with calcification in mammography, multifocal multicentric lesions, and non-mass enhancement in pretreatment MR imaging are significantly associated with false-negative results who showed rCR on MR imaging after NAC. These patient populations should be interpreted with caution.

Prognostic factors predicting recurrence in invasive breast cancer: An analysis of radiological and clinicopathological factors.

BACKGROUND/OBJECTIVE: The purpose of this study was to perform a comprehensive analysis of the radiological and clinicopathological factors that could predict recurrence of invasive breast cancer who underwent curative surgery without neoadjuvant chemotherapy. METHODS: Three hundred and sixty-four consecutive women who underwent preoperative mammography, ultrasound, and breast magnetic resonance imaging for newly diagnosed invasive breast cancers and curative surgery between January and December 2010 were included. We analyzed the radiological findings of each modality and reviewed the histopathological features. A Cox proportional hazards model was used to determine the association between the radiological and clinicopathological parameters and disease-free survival (DFS). RESULTS: During the median follow-up period of 5.3 years, 23 patients (6.3%) developed recurrences: locoregional recurrence in six patients, contralateral breast recurrence in three patients, and distant recurrences in 14 patients. Microcalcifications on mammography showed a tendency towards worse DFS. The multivariate Cox regression analysis showed that presence of lymphovascular invasion (LVI) (p = 0.006), negative progesterone receptor (PR) status (p < 0.001), and positive CK5/6 expression (p = 0.015) were independent significant variables predictive of worse DFS. CONCLUSION: Understanding the prognostic factors in patients with invasive breast cancer may provide considerable practical information about future treatment strategies.

Sonographic features that can be used to differentiate between small triple-negative breast cancer and fibroadenoma.

PURPOSE: Our study investigated whether any sonographic findings could be useful for differentiating between small triple-negative breast cancer (TNBC) and fibroadenoma. METHODS: This retrospective study was approved by our Institutional Review Board, which waived the requirement for patient consent. From January 2009 to December 2010, the sonographic features of 181 pathologically proven TNBC tumors and 172 fibroadenomas measuring less than or equal to 2 cm in the longest dimension were reviewed and analyzed according to the fifth edition of the Breast Imaging Reporting and Data System (BI-RADS) lexicon. Mean tumor roundness was also measured using in-house software. RESULTS: The median longest lesion dimension was 16 mm (range, 13 to 18 mm) in TNBCs and 13 mm (range, 10 to 16 mm) in fibroadenomas. In comparison to fibroadenomas, small TNBC tumors presented with a higher incidence of irregular shapes (66.9%), noncircumscribed margins (91.7%), hypoechoic echotexture (59.1%), posterior acoustic enhancement (65.2%), and associated features (24.4%). Most TNBCs were classified as BI-RADS category 4 (65.2%) or 5 (28.2%). The mean tumor roundness of small TNBCs was greater than that of fibroadenomas (60%±12% vs. 53%±13%). Multivariate analysis showed that older patient age, irregular shape, nonparallel orientation, posterior acoustic enhancement, associated features, a BI-RADS final assessment category of 4 or 5, and greater tumor roundness were significant independent factors indicative of TNBCs. CONCLUSION: TNBC tumors tend to demonstrate more suspicious sonographic features and greater tumor roundness than fibroadenomas. These features may have the potential to help differentiate between small TNBCs and fibroadenomas.

The efficacy and safety of the herbal medicine geonchildan for patients with active rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled, parallel pilot trial.

BACKGROUND: This study aims to assess the efficacy and safety of geonchildan, a Korean traditional herbal medicine, for patients with active rheumatoid arthritis (RA) and evaluate the feasibility of a large-scale confirmatory clinical trial. METHODS/DESIGN: This is a randomized, double-blind, placebo-controlled, parallel two-arm pilot trial in Seoul, Korea. Altogether, 30 patients diagnosed with RA for at least 3 months and with a Disease Activity Score for 28 joints (DAS28) ≥ 3.2 will be enrolled. Participants are randomly assigned to one of two groups, the experimental group or the placebo group, in a 1:1 ratio and will make four scheduled visits. The participants will be administered geonchildan or a placebo three times per day for 12 weeks. The change in DAS28 will be examined as the primary efficacy outcome. The secondary efficacy outcomes include the proportion of patients achieving ACR20, ACR50, ACR70, and EULAR responses; the DAS28 sub-items; the consumption of medication; Korean Health Assessment Questionnaire scores; inflammatory parameters; and the Korean medical diagnostic pattern indicator. Adverse events and laboratory test results will be recorded to evaluate safety. The process, resources used, and management of the study will also be assessed to determine the feasibility of a large-scale trial. DISCUSSION: This is the first clinical trial to explore the efficacy and safety of geonchildan in patients with active RA. If the superiority of geonchildan versus the placebo is demonstrated and the study design is feasible, this study could form the foundation for a large-scale clinical trial. The results will be published in a peer-reviewed journal. TRIAL REGISTRATION: Clinical Research Information Service, KCT0001943 . Registered on 14 June 2016.