This paper aims to discuss the issues needed to be considered during the process of defining the registered product standards and industry standards of digital mammographic X-ray camera system. Meanwhile, for the future reference of establishment of standards, it adds the additional technical requirements not only from the features of device's structure, but also from the risk of clinical use.
Mammography ; instrumentation ; standards ; Radiographic Image Enhancement ; instrumentation

OBJECTIVE: The goal of this study is to compare the overall quality of film mammograms taken according to the Korean standards with the American College of Radiology (ACR) standard for clinical image evaluation and to identify means of improving mammography quality in Korea. MATERIALS AND METHODS: Four hundred and sixty eight sets of film mammograms were evaluated with respect to the Korean and ACR standards for clinical image evaluation. The pass and failure rates of mammograms were compared by medical facility types. Average scores in each category of the two standards were evaluated. Receiver operating characteristic curve analysis was used to identify an optimal Korean standard pass mark by taking the ACR standard as the reference standard. RESULTS: 93.6% (438/468) of mammograms passed the Korean standard, whereas only 80.1% (375/468) passed the ACR standard (p < 0.001). Non-radiologic private clinics had the lowest pass rate (88.1%: Korean standard, 71.8%: ACR standard) and the lowest total score (76.0) by the Korean standard. Average scores of positioning were lowest (19.3/29 by the Korean standard and 3.7/5 by the ACR standard). A cutoff score of 77.0 for the Korean standard was found to correspond to a pass level when the ACR standard was applied. CONCLUSION: We suggest that tighter regulations, such as, raising the Korean pass mark, subtracting more for severe deficiencies, or considering a very low scores in even a single category as failure, are needed to improve the quality of mammography in Korea.
Accreditation/*standards ; Female ; Humans ; Mammography/*standards ; *Quality Improvement ; ROC Curve ; Republic of Korea ; Retrospective Studies

In this paper, the focus of technical review of the registration application data of digital Breast Tomosynthesis Mammography System was sorted out, so as to provide reference for researchers and manufacturers in China when applying for registration and preparation of such products.
Breast ; diagnostic imaging ; Breast Neoplasms ; diagnostic imaging ; China ; Humans ; Mammography ; instrumentation ; standards ; Radiographic Image Enhancement ; standards ; Risk Factors

OBJECTIVE: To evaluate the efficacy of a mammography boot camp (MBC) to improve radiologists' performance in interpreting mammograms in the National Cancer Screening Program (NCSP) in Korea. MATERIALS AND METHODS: Between January and July of 2013, 141 radiologists were invited to a 3-day educational program composed of lectures and group practice readings using 250 digital mammography cases. The radiologists' performance in interpreting mammograms were evaluated using a pre- and post-camp test set of 25 cases validated prior to the camp by experienced breast radiologists. Factors affecting the radiologists' performance, including age, type of attending institution, and type of test set cases, were analyzed. RESULTS: The average scores of the pre- and post-camp tests were 56.0 +/- 12.2 and 78.3 +/- 9.2, respectively (p < 0.001). The post-camp test scores were higher than the pre-camp test scores for all age groups and all types of attending institutions (p < 0.001). The rate of incorrect answers in the post-camp test decreased compared to the pre-camp test for all suspicious cases, but not for negative cases (p > 0.05). CONCLUSION: The MBC improves radiologists' performance in interpreting mammograms irrespective of age and type of attending institution. Improved interpretation is observed for suspicious cases, but not for negative cases.
Adult ; Aged ; Breast Neoplasms/*radiography ; Education, Medical, Continuing/*standards ; Education, Professional, Retraining ; Female ; Humans ; Male ; *Mammography ; Middle Aged

OBJECTIVE: The goal of the study was to compare conventional mammography (MG) and contrast-enhanced spectral mammography (CESM) in preoperative women. MATERIALS AND METHODS: The study was approved by the local Ethics Committee and all participants provided informed consent. The study included 152 consecutive patients with 173 breast lesions diagnosed on MG or CESM. All MG examinations and consults were conducted in one oncology centre. Non-ionic contrast agent, at a total dose of 1.5 mL/kg body weight, was injected intravenous. Subsequently, CESM exams were performed with a mammography device, allowing dual-energy acquisitions. The entire procedure was done within the oncology centre. Images from low and high energy exposures were processed together and the combination provided an "iodine" image which outlined contrast up-take in the breast. RESULTS: MG detected 157 lesions in 150 patients, including 92 infiltrating cancers, 12 non-infiltrating cancers, and 53 benign lesions. CESM detected 149 lesions in 128 patients, including 101 infiltrating cancers, 13 non-infiltrating cancers, and 35 benign lesions. CESM sensitivity was 100% (vs. 91% for MG), specificity was 41% (vs. 15% for MG), area under the receiver operating characteristic curve was 0.86 (vs. 0.67 for MG), and accuracy was 80% (vs. 65% for MG) for the diagnosis of breast cancer. Both MG and CESM overestimated lesion sizes compared to histopathology (p < 0.001). CONCLUSION: CESM may provide higher sensitivity for breast cancer detection and greater diagnostic accuracy than conventional mammography.
Adult ; Aged ; Aged, 80 and over ; Area Under Curve ; Breast/*pathology ; Breast Neoplasms/diagnosis/*pathology ; Contrast Media/diagnostic use ; Diagnosis, Differential ; Female ; Humans ; Mammography/*standards ; Middle Aged ; ROC Curve ; Sensitivity and Specificity

OBJECTIVE: To determine, by means of long-term follow-up evaluation, the outcome and accuracy of stereotactic core-needle biopsy (SCNB) of non-mass calcifications observed at mammography, and to analyze the factors contributing to false-negative findings. MATERIALS AND METHODS: Using a 14-gauge needle, SCNB was performed in cases involving 271 non-mass calcified lesions observed at mammography in 267 patients aged 23 72 (mean, 47) years. We compared the SCNB results with those of long-term follow-up which included surgery, mammography performed for at least six months, and reference to Korean Cancer Registry listings. We investigated the retrieval rate for calcifications observed at specimen mammography and histologic evaluation, and determined the incidence rate of cancer, sensitivity, and the underestimation rate for SCNB. False-negative cases were evaluated in terms of their mammographic findings, the effect of the operators' experience, and the retrieval rate for calcifications. RESULTS: For specimen mammography and histologic evaluation of SCNB, the retrieval rate for calcifications was, respectively, 84% and 77%. At SCNB, 54 of 271 lesions (19.9%) were malignant [carcinoma in situ, 45/54 (83%) ], 16 were borderline, and 201 were benign. SCNB showed that the incidence of cancer was 5.0% (6/120) in the benign mammographic category and 31.8% (48/151) in the malignant category. The findings revealed by immediate surgery and by longterm follow-up showed, respectively, that the sensitivity of SCNB was 90% and 82%. For borderline lesions, the underestimation rate was 10%. For false-negative cases, which were more frequent among the first ten cases we studied (p = 0.01), the most frequent mammographic finding was clustered amorphous calcifications. For true-negative and false-negative cases, the retrieval rate for calcifications was similar at specimen mammography (83% and 67%, respectively; p = 0.14) and histologic evaluation (79% and 75%, respectively; p = 0.47). CONCLUSION: In this study group, most diagnosed cancers were in-situ lesions, and long-term follow-up showed that the sensitivity of SCNB was 82%. Falsenegative findings were frequent during the operators' learning period.
Adult ; Aged ; Biopsy, Needle/*methods/standards/statistics & numerical data ; Breast/*pathology/surgery ; Breast Neoplasms/*diagnosis/epidemiology/surgery ; Calcinosis/*diagnosis/epidemiology/surgery ; Carcinoma in Situ/*diagnosis/epidemiology/surgery ; Diagnosis, Differential ; Disease Progression ; False Negative Reactions ; Female ; Follow-Up Studies ; Human ; Incidence ; Mammography/statistics & numerical data ; Middle Aged ; Reproducibility of Results ; Sensitivity and Specificity ; Time Factors ; Treatment Outcome