Diffusion-Weighted Magnetic Resonance Imaging for Preoperative Evaluation of Patients With Breast Cancer: Protocol of a Prospective, Multicenter, Observational Cohort Study / 한국유방암학회지

Purpose@#Detection of multifocal, multicentric, and contralateral breast cancers in patients affects surgical management. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can identify additional foci that were initially undetected by conventional imaging. However, its use is limited owing to low specificity and high false-positive rate. Multiparametric MRI (DCE-MRI + diffusion-weighted [DW] MRI) can increase the specificity. We aimed to describe the protocols of our prospective, multicenter, observational cohort studies designed to compare the diagnostic performance of DCE-MRI and multiparametric MRI for the diagnosis of multifocal, multicentric cancer and contralateral breast cancer in patients with newly diagnosed breast cancer. @*Methods@#Two studies comparing the performance of DCE-MRI and multiparametric MRI for the diagnosis of multifocal, multicentric cancer (NCT04656639) and contralateral breast cancer (NCT05307757) will be conducted. For trial NCT04656639, 580 females with invasive breast cancer candidates for breast conservation surgery whose DCE-MRI showed additional suspicious lesions (breast imaging reporting and data system [BI-RADS] category ≥ 4) on DCE-MRI in the ipsilateral breast will be enrolled. For trial NCT05307757, 1098 females with invasive breast cancer whose DCE-MRI showed contralateral lesions (BI-RADS category ≥ 3 or higher on DCE-MRI) will be enrolled. Participants will undergo 3.0-T DCE-MRI and DWMRI. The diagnostic performance of DCE-MRI and multiparametric MRI will be compared.The receiver operating characteristic curve, sensitivity, specificity, positive predictive value, and characteristics of the detected cancers will be analyzed. The primary outcome is the difference in the receiver operating characteristic curve between DCE-MRI and multiparametric MRI interpretation. Enrollment completion is expected in 2024, and study results are expected to be presented in 2026.Discussion: This prospective, multicenter study will compare the performance of DCE-MRI versus multiparametric MRI for the preoperative evaluation of multifocal, multicentric, and contralateral breast cancer and is currently in the patient enrollment phase.

Diffusion-Weighted Magnetic Resonance Imaging for Breast Cancer Screening in High-Risk Women: Design and Imaging Protocol of a Prospective Multicenter Study in Korea / 한국유방암학회지

Purpose@#Interest in unenhanced magnetic resonance imaging (MRI) screening for breast cancer is growing due to concerns about gadolinium deposition in the brain and the high cost of contrast-enhanced MRI. The purpose of this report is to describe the protocol of the Diffusion-Weighted Magnetic Resonance Imaging Screening Trial (DWIST), which is a prospective, multicenter, intraindividual comparative cohort study designed to compare the performance of mammography, ultrasonography, dynamic contrast-enhanced (DCE) MRI, and diffusion-weighted (DW) MRI screening in women at high risk of developing breast cancer. @*Methods@#A total of 890 women with BRCA mutation or family history of breast cancer and lifetime risk ≥ 20% are enrolled. The participants undergo 2 annual breast screenings with digital mammography, ultrasonography, DCE MRI, and DW MRI at 3.0 T. Images are independently interpreted by trained radiologists. The reference standard is a combination of pathology and 12-month follow-up. Each image modality and their combination will be compared in terms of sensitivity, specificity, accuracy, positive predictive value, rate of invasive cancer detection, abnormal interpretation rate, and characteristics of detected cancers. The first participant was enrolled in April 2019. At the time of manuscript submission, 5 academic medical centers in South Korea are actively enrolling eligible women and a total of 235 women have undergone the first round of screening. Completion of enrollment is expected in 2022 and the results of the study are expected to be published in 2026.Discussion: DWIST is the first prospective multicenter study to compare the performance of DW MRI and conventional imaging modalities for breast cancer screening in high-risk women. DWIST is currently in the patient enrollment phase.

Prior to Breast MRI Guidelines in Korea, Where Were We?

Purpose@#To evaluate and analyze the adequacy of breast magnetic resonance imaging (MRI)s taken before publication of the 2018 recommendation in South Korea. @*Materials and Methods@#We enrolled 87 cases of breast MRIs, from January 2010 to November 2013, taken at external hospitals in the study. Breast MRI protocol elements are divided into three categories based on the recommendation by the Breast Imaging Study Group of the Korean Society of Magnetic Resonance: (1) Essential elements for breast MRI protocol; (2) Element to consider when evaluating imaging quality; and (3) Optional element for breast MRI protocol. Also, we divided enrolled cases into three groups based on their conducting locations -- (1) Primary hospitals, (2) Secondary hospitals, and (3) Tertiary hospitals-and analyzed them for the adequacy of imaging protocols based on the 2018 recommendation. We used a Chi-square test and Fisher’s exact test to identify differences between categorical variables. @*Results@#Over 98% of the criteria for 'essential elements for breast MRI protocol' were satisfied when compared with the 2018 Recommendation. Over 96% of the criteria for 'elements to consider when evaluating imaging quality' were also satisfied, except for the slice thickness (83.9%). Optional elements for breast MRI protocol were satisfied with various percentages. There were no statistically significant differences between groups of tertiary, secondary, and primary hospitals; however, 3 tesla of MRI (P = 0.04), subtraction image protocol (P = 0.032), and DWI protocol (P = 0.03) were used more frequently in the tertiary hospitals than in the others. @*Conclusion@#We found that the categories of 'essential elements' and 'elements to consider when evaluating imaging quality' were satisfied at 98% and 96%, respectively, when compared with the 2018 Recommendation by the Breast Imaging Study Group of the Korean Society of Magnetic Resonance.

Diffusion-Weighted Magnetic Resonance Imaging for Breast Cancer Screening in High-Risk Women: Design and Imaging Protocol of a Prospective Multicenter Study in Korea / 한국유방암학회지

Purpose@#Interest in unenhanced magnetic resonance imaging (MRI) screening for breast cancer is growing due to concerns about gadolinium deposition in the brain and the high cost of contrast-enhanced MRI. The purpose of this report is to describe the protocol of the Diffusion-Weighted Magnetic Resonance Imaging Screening Trial (DWIST), which is a prospective, multicenter, intraindividual comparative cohort study designed to compare the performance of mammography, ultrasonography, dynamic contrast-enhanced (DCE) MRI, and diffusion-weighted (DW) MRI screening in women at high risk of developing breast cancer. @*Methods@#A total of 890 women with BRCA mutation or family history of breast cancer and lifetime risk ≥ 20% are enrolled. The participants undergo 2 annual breast screenings with digital mammography, ultrasonography, DCE MRI, and DW MRI at 3.0 T. Images are independently interpreted by trained radiologists. The reference standard is a combination of pathology and 12-month follow-up. Each image modality and their combination will be compared in terms of sensitivity, specificity, accuracy, positive predictive value, rate of invasive cancer detection, abnormal interpretation rate, and characteristics of detected cancers. The first participant was enrolled in April 2019. At the time of manuscript submission, 5 academic medical centers in South Korea are actively enrolling eligible women and a total of 235 women have undergone the first round of screening. Completion of enrollment is expected in 2022 and the results of the study are expected to be published in 2026.Discussion: DWIST is the first prospective multicenter study to compare the performance of DW MRI and conventional imaging modalities for breast cancer screening in high-risk women. DWIST is currently in the patient enrollment phase.

Prior to Breast MRI Guidelines in Korea, Where Were We?

Purpose@#To evaluate and analyze the adequacy of breast magnetic resonance imaging (MRI)s taken before publication of the 2018 recommendation in South Korea. @*Materials and Methods@#We enrolled 87 cases of breast MRIs, from January 2010 to November 2013, taken at external hospitals in the study. Breast MRI protocol elements are divided into three categories based on the recommendation by the Breast Imaging Study Group of the Korean Society of Magnetic Resonance: (1) Essential elements for breast MRI protocol; (2) Element to consider when evaluating imaging quality; and (3) Optional element for breast MRI protocol. Also, we divided enrolled cases into three groups based on their conducting locations -- (1) Primary hospitals, (2) Secondary hospitals, and (3) Tertiary hospitals-and analyzed them for the adequacy of imaging protocols based on the 2018 recommendation. We used a Chi-square test and Fisher’s exact test to identify differences between categorical variables. @*Results@#Over 98% of the criteria for 'essential elements for breast MRI protocol' were satisfied when compared with the 2018 Recommendation. Over 96% of the criteria for 'elements to consider when evaluating imaging quality' were also satisfied, except for the slice thickness (83.9%). Optional elements for breast MRI protocol were satisfied with various percentages. There were no statistically significant differences between groups of tertiary, secondary, and primary hospitals; however, 3 tesla of MRI (P = 0.04), subtraction image protocol (P = 0.032), and DWI protocol (P = 0.03) were used more frequently in the tertiary hospitals than in the others. @*Conclusion@#We found that the categories of 'essential elements' and 'elements to consider when evaluating imaging quality' were satisfied at 98% and 96%, respectively, when compared with the 2018 Recommendation by the Breast Imaging Study Group of the Korean Society of Magnetic Resonance.

Survival Rates of Breast Cancer Patients Aged 40 to 49 Years according to Detection Modality in Korea: Screening Ultrasound versus Mammography

Objective@#The aim of this study was to compare the survival rates of Korean females aged 40 to 49 years with breast cancer detected by supplemental screening ultrasound (US) or screening mammography alone. @*Materials and Methods@#This single-institution retrospective study included 240 patients with breast cancer (mean age, 45.1 ± 2.8 years) detected by US or mammography who had undergone breast surgery between 2003 and 2008. Medical records were reviewed for clinicopathologic characteristics and detection methods. Disease-free survival (DFS) and overall survival (OS) were compared between patients with breast cancer in the US and mammography groups using the log-rank test. Multivariable cox regression analysis was used to identify independent variables associated with DFS and OS. @*Results@#Among the 240 cases of breast cancer, 43 were detected by supplemental screening US and 197 by screening mammography (mean follow-up: 7.4 years, 93.3% with dense breasts). There were 19 recurrences and 16 deaths, all occurring in the mammography group. While the US group did not differ from the mammography group in tumor stage, the patients in this group were more likely to undergo breast-conserving surgery and radiation therapy than the mammography group.The US group also showed better DFS (p = 0.016); however, OS did not differ between the two groups (p = 0.058). In the multivariable analysis, the US group showed a lower risk of recurrence (hazard ratio, 0.097; 95% confidence interval, 0.001–0.705) compared to the mammography group. @*Conclusion@#Our study found that Korean females aged 40–49 years with US-detected breast cancer showed better DFS than those with mammography-detected breast cancer. However, there were no statistically significant differences in OS.

Follow-Up Intervals for Breast Imaging Reporting andData System Category 3 Lesions on Screening Ultrasoundin Screening and Tertiary Referral Centers

Objective@#To assess the appropriate follow-up interval, and rate and timepoint of cancer detection in women with Breast ImagingReporting and Data System (BI-RADS) 3 lesions on screening ultrasonography (US) according to the type of institution. @*Materials and Methods@#A total of 1451 asymptomatic women who had negative or benign findings on screening mammogram,BI-RADS 3 assessment on screening US, and at least 6 months of follow-up were included. The median follow-up interval was30.8 months (range, 6.8–52.9 months). The cancer detection rate, cancer detection timepoint, risk factors, and clinicopathologicalcharacteristics were compared between the screening and tertiary centers. Nominal variables were compared using the chisquareor Fisher’s exact test and continuous variables were compared using the independent t test or Mann-Whitney U test. @*Results@#In 1451 women, 19 cancers (1.3%) were detected; two (0.1%) were diagnosed at 6 months and 17 (1.2%) werediagnosed after 12.3 months. The malignancy rates were both 1.3% in the screening (9 of 699) and tertiary (10 of 752) centers.In the screening center, all nine cancers were invasive cancers and diagnosed after 12.3 months. In the tertiary center, twowere ductal carcinomas in situ and eight were invasive cancers. Two of the invasive cancers were diagnosed at 6 months andthe remaining eight cancers newly developed after 13.1 months. @*Conclusion@#One-year follow-up rather than 6-month follow-up may be suitable for BI-RADS 3 lesions on screening US foundin screening centers. However, more caution is needed regarding similar findings in tertiary centers where 6-month follow-upmay be more appropriate.

Diagnostic Value of CYFRA 21-1 Measurement in Fine-Needle Aspiration Washouts for Detection of Axillary Recurrence in Postoperative Breast Cancer Patients

PURPOSE@#The objective of this study was to evaluate the diagnostic value and threshold levels of cytokeratin fragment 21-1 (CYFRA 21-1) in fine-needle aspiration (FNA) washouts for detection of lymph node (LN) recurrence in postoperative breast cancer patients.@*MATERIALS AND METHODS@#FNA cytological assessments and CYFRA 21-1 measurement in FNA washouts were performed for 64 axillary LNs suspicious for recurrence in 64 post-operative breast cancer patients. Final diagnosis was made on the basis of FNA cytology and follow-up data over at least 2 years. The concentration of CYFRA 21-1 was compared between recurrent LNs and benign LNs. Diagnostic performance and cut-off value were evaluated using a receiver operating characteristic curve.@*RESULTS@#Regardless of the non-diagnostic results, the median concentration of CYFRA 21-1 in recurrent LNs was significantly higher than that in benign LNs (p < 0.001). The optimal diagnostic cut-off value was 1.6 ng/mL. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of CYFRA 21-1 for LN recurrence were 90.9%, 100%, 100%, 98.1%, and 98.4%, respectively.@*CONCLUSION@#Measurement of CYFRA 21-1 concentration from ultrasound-guided FNA biopsy aspirates showed excellent diagnostic performance with a cut-off value of 1.6 ng/mL. These results indicate that measurement of CYFRA 21-1 concentration in FNA washouts is useful for the diagnosis of axillary LN recurrence in post-operative breast cancer patients.

Annual Trends in Ultrasonography-Guided 14-Gauge Core Needle Biopsy for Breast Lesions

OBJECTIVE: To examine time trends in ultrasonography (US)-guided 14-gauge core needle biopsy (CNB) for breast lesions based on the lesion size, Breast Imaging-Reporting and Data System (BI-RADS) category, and pathologic findings.MATERIALS AND METHODS: We retrospectively reviewed consecutive US-guided 14-gauge CNBs performed from January 2005 to December 2016 at our institution. A total of 22,297 breast lesions were included. The total number of biopsies, tumor size (≤ 10 mm to > 40 mm), BI-RADS category (1 to 5), and pathologic findings (benign, high risk, ductal carcinoma in situ [DCIS], invasive cancer) were examined annually, and the malignancy rate was analyzed based on the BI-RADS category.RESULTS: Both the total number of US scans and US-guided CNBs increased while the proportion of US-guided CNBs to the total number of US scans decreased significantly. The number of biopsies classified based on the tumor size, BI-RADS category, and pathologic findings all increased over time, except for BI-RADS categories 1 or 2 and category 3 (odds ratio [OR] = 0.951 per year, 95% confidence interval [CI]: 0.902, 1.002 and odds ratio = 0.979, 95% CI: 0.970, 0.988, respectively). Both the unadjusted and adjusted total malignancy rates and the DCIS rate increased significantly over time. BI-RADS categories 4a, 4b, and 4c showed a significant increasing trend in the total malignancy rate and DCIS rate.CONCLUSION: The malignancy rate in the results of US-guided 14-gauge CNB for breast lesions increased as the total number of biopsies increased from 2005 to 2016. This trend persisted after adjusting for the BI-RADS category.

Core-Needle Biopsy Does Not Show Superior Diagnostic Performance to Fine-Needle Aspiration for Diagnosing Thyroid Nodules

Medical Audit of Screening Mammography at a Tertiary Referral Hospital Using the 5th Edition of Breast Imaging Reporting and Data System

PURPOSE@#The purpose of this study is to analyze medical audit of screening digital mammography at a tertiary hospital and to review changes of medical audit according to newly revised standard.@*MATERIALS AND METHODS@#We analyzed 7764 asymptomatic women who underwent screening mammogram at our hospital from January, 2013 to December, 2014. The family or past history of breast, gynecologic and other cancers was reviewed retrospectively. Analysis 1 defined category 3 as positive result and analysis 2 defined category 3 as negative.@*RESULTS@#The overall cancer detection rate was 4.6 per 1000 cases. The cancer detection rate in patients with non-gynecological and non-thyroid cancer (n = 391, 51.2) was the highest compared to patients with family history of breast cancer (n = 691, 1.4), or gynecological cancer (n = 311, 12.9). In analysis 1, positive predictive value 1 decreased 1.3% (6.0% vs. 7.3%) and recall rate increased 1.3% (7.3% vs. 6.0%) compared with analysis 2. The results were appropriate for newly revised target.@*CONCLUSION@#The results of screening digital mammography in the tertiary medical institution showed excellent results even if category 3 was regarded as positive. In addition, screening tests for secondary cancer are needed in the tertiary hospital.

Comparison of breast tissue markers for tumor localization in breast cancer patients undergoing neoadjuvant chemotherapy

PURPOSE: The purpose of this study was to compare the visibility of breast tissue markers in cases of breast cancer on ultrasonography (US) after neoadjuvant chemotherapy (NAC) and to analyze whether the type of marker affected the choice of localization method after NAC. METHODS: We included 153 tissue markers inserted within breast cancers that showed pathologically complete response (pCR) after NAC from January 2012 to April 2017. One of three types of markers (a surgical clip, Cormark, or UltraClip) was inserted. Medical records and imaging findings were retrospectively reviewed. We compared the visibility of the different types of tissue markers on US after NAC, and also compared the imaging modalities used in the preoperative localization. The chi-square test, Fisher exact test, and multiple logistic regression were used for analysis. RESULTS: Of the 153 tissue markers, 56 were surgical clips, 61 Cormark, and 36 UltraClip. After NAC, residual lesions were not seen on US in 42 cases (27.5%). In multivariate analysis, the visibility of the surgical clips and Cormark markers was better than that of the UltraClip markers (odds ratio [OR], 5.467; 95% confidence interal [CI], 1.717 to 17.410; P=0.004 and OR, 3.045; 95% CI, 1.074 to 8.628; P=0.036, respectively). Among the 131 cases where localization targeting the marker was required, the proportion of US-guided localizations was significantly higher when a surgical clip was used than when an UltraClip marker was used (OR, 5.566; 95% CI, 1.610 to 19.246; P=0.007) in the multivariate analysis. CONCLUSION: The type of breast tissue marker affected its visibility on US in cases with pCR after NAC, which in turn affected the localization methodology.

Feasibility of Charcoal Tattooing of Cytology-Proven Metastatic Axillary Lymph Node at Diagnosis and Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy in Breast Cancer Patients / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: Sentinel lymph node biopsy (SLNB) can be performed when node-positive disease is converted to node-negative status after neoadjuvant chemotherapy (NCT). Tattooing nodes might improve accuracy but supportive data are limited. This study aimed to investigate the feasibility of charcoal tattooing metastatic axillary lymph node (ALN) at presentation followed by SLNB after NCT in breast cancers. MATERIALS AND METHODS: Twenty patientswith cytology-proven node metastases prospectively underwent charcoal tattooing at diagnosis. SLNB using dual tracers and axillary surgery after NCT were then performed. The detection rate of tattooed node and diagnostic performance of SLNB were analyzed. RESULTS: All patients underwent charcoal tattooingwithout significant morbidity. Sentinel and tattooed nodes could be detected during surgery after NCT. Nodal pathologic complete response was achieved in 10 patients. Overall sensitivity, false-negative rate (FNR), negative predictive value, and accuracy of hot/blue SLNB were 80.0%, 20.0%, 83.3%, and 90.0%, respectively. Retrieving more nodes and favorable nodal response were associated with improved performance. The best accuracy was observed when excised tattooed node was calculated together (FNR, 0.0%). Cold/non-blue tattooed nodes of five patients were removed during non-sentinel axillary surgery but clinicopathological parameters did not differ compared to patients with hot/blue tattooed node detected during SLNB, suggesting the importance of the tattooing procedure itself to improve performance. CONCLUSION: Charcoal tattooing of cytology-confirmed metastatic ALN at presentation is technically feasible and does not limit SLNB after NCT. The tattooing procedure without additional preoperative localization is advantageous for improving the diagnostic performance of SLNB in this setting.

Evaluating imaging-pathology concordance and discordance after ultrasound-guided breast biopsy

Ultrasound (US)-guided breast biopsy has become the main method for diagnosing breast pathology, and it has a high diagnostic accuracy, approaching that of open surgical biopsy. However, methods for confirming adequate lesion retrieval after US-guided biopsy are relatively limited and false-negative results are unavoidable. Determining imaging-pathology concordance after US-guided biopsy is essential for validating the biopsy result and providing appropriate management. In this review article, we briefly present the results of US-guided breast biopsy; describe general aspects to consider when establishing imaging-pathology concordance; and review the various categories of imaging-pathology correlations and corresponding management strategies.

Associations between Bethesda categories and tumor characteristics of conventional papillary thyroid carcinoma

PURPOSE: The aim of this study was to investigate the associations of Bethesda categories III, V, and VI with the clinical and pathological features of thyroid nodules surgically confirmed as conventional papillary thyroid carcinomas (PTCs). METHODS: We analyzed 1,990 consecutive patients diagnosed with conventional PTC at surgery with preoperative Bethesda categories III, V, or VI. We determined the odds ratio (ORs) of the clinical and pathological variables associated with categories III and V, using category VI as the reference. RESULTS: Category III and V PTCs had a smaller pathological tumor size (OR, 0.934 and OR, 0.969, respectively) and less frequently had central lymph node metastasis (OR, 0.487 and OR, 0.780, respectively) than category VI PTCs. Category III PTCs less frequently showed suspicious ultrasonographic features (OR, 0.296) than category VI PTCs, and category V PTCs less frequently had gross extrathyroidal extension, with borderline significance (OR, 0.643; P=0.059). CONCLUSION: Conventional PTCs with a preoperative Bethesda category of III or V may less frequently exhibit poor prognostic factors than those with malignant cytology.