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

To evaluate the influence of 3- and 5-megapixel medical professional monitors in detecting the micro-calcifications on high- and low-resolution breast images, we performed a retrospective study in low- (n = 100) and high-resolution (n = 100) data, including 40 micro-calcification patients in a group and 60 normal ones in control group respectively. Two doctors, one junior, and the other senior, reviewed all the images without knowing the clinical data and histology, and their observations of each image with different monitors were calculated. The areas under the ROC curves (Az) were compared. Finally, the interpretation consistency of the two doctors was assessed using Kappa analysis. In the low resolution data group, the two doctors' detection performance of breast micro-calcifications were very similar in the 3M and 5M medical professional monitors (P = 0.451 and 0.559). In the high resolution group, however, the senior doctor's recognition rate on the 5M monitor was significantly higher than that on the 3M (P = 0.022), while the junior's recognition rate had no significant difference (P = 0.141) between the two readings. The two doctors' interpretation consistency on 5M monitor was better than that on 3M monitor. For the high-resolution images on the 5M monitor, the interpretation of the two doctors had extremely great consistency (K = 0.862). Therefore, different breast images of different resolutions should match corresponding resolution monitor. Interpretation of high-resolution images with 5M monitor has more advantages in the micro-calcification detection for senior doctors.
Adult ; Aged ; Aged, 80 and over ; Breast ; pathology ; Breast Neoplasms ; diagnostic imaging ; Calcinosis ; diagnostic imaging ; Female ; Humans ; Mammography ; instrumentation ; Middle Aged ; Observer Variation ; ROC Curve ; Radiographic Image Interpretation, Computer-Assisted ; instrumentation ; Reproducibility of Results ; User-Computer Interface

OBJECTIVETo evaluate the diagnostic value of ultrasonography in combination with mammography for breast cancer within 2 cm.

METHODSThe PubMed, the Cochrane Library, CNKI, CBM and Wanfang databases (2003/01/01-2013/04/30) were searched for studies of the diagnostic value of ultrasonography in combination with mammography for breast cancer within 2 cm. The quality of the included studies was evaluated according to QUADAS items. The pooled sensitivity (SEN), pooled specificity (SPE), pooled diagnostic odds ratio (DOR), and area under summary receiver operating characteristic curve (AUC) were calculated using Review Manager 5.2 and Meta-DiSc 1.4 software.

RESULTSNine articles were included in the final analysis. The pooled SEN of ultrasonography, mammography and their combination were 0.75, 0.66, and 0.92, the pooled SPE 0.75, 0.83, and 0.82, the pooled DOR 7.11, 8.67, and 60.82, and the AUC 0.7902, 0.8120, and 0.9469, respectively.

CONCLUSIONThe combination of ultrasonography and mammography can increase the diagnostic accuracy for breast cancer within 2 cm.

Breast Neoplasms ; diagnostic imaging ; pathology ; Early Detection of Cancer ; Female ; Humans ; Mammography ; instrumentation ; methods ; Molybdenum ; ROC Curve ; Sensitivity and Specificity ; Ultrasonography, Doppler, Color ; Ultrasonography, Doppler, Pulsed ; Ultrasonography, Mammary ; methods

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

With the widespread clinical application of neoadjuvant chemotherapy, it has become an essential part of combination therapy for patients with breast cancer. However, a rapid, accurate, and effective approach for assessing the therapeutic efficacy of neoadjuvant chemotherapy is unavailable. Routine physical examinations cannot provide effective clinical evaluation. Although imaging techniques play an important role in evaluating the therapeutic effect of neoadjuvant chemotherapy, this is limited because it only detects morphologic changes. Blood oxygen detection for breast diseases is an emerging diagnostic technique that has distinctive merit in assessing the efficacy of chemotherapy. Biologic markers are becoming more important in assessing the effect of neoadjuvant chemotherapy for patients with breast cancer. This review summarizes the principles and the current applied practice of these approaches to evaluate the effect of neoadjuvant chemotherapy for patients with breast cancer.
Biomarkers, Tumor ; metabolism ; Breast Neoplasms ; diagnosis ; drug therapy ; metabolism ; Chemotherapy, Adjuvant ; Evaluation Studies as Topic ; Female ; Humans ; Magnetic Resonance Imaging ; Mammography ; instrumentation ; Molybdenum ; Neoadjuvant Therapy ; Oxyhemoglobins ; metabolism ; Positron-Emission Tomography ; Ultrasonography, Mammary

OBJECTIVE: To improve the performance quality of mammography X-ray system, and to decrease misdiagnoses. METHODS: Quality assurance was tested and controlled from such aspect as measurement of half value layer, beam quality assessment, breast entrance exposure average glandular dose, tube tunsion accuracy and reproducibility, and radiation output. RESULTS: The image contrast, mistiness and noise were optimized. CONCLUSION With the quality assurance of the digital mammography X-ray system, the variations of the performance parameters remain in the range of permission, thus improving the quality of mammography.
Humans ; Image Enhancement ; instrumentation ; Mammography ; instrumentation ; methods ; Quality Control ; Radiographic Image Enhancement ; instrumentation

OBJECTIVE: To evaluate the efficacy for spatial resolution and radiation dose of a small-field digital mammographic imaging system using parabolic polycapillary optics. MATERIALS AND METHODS: We developed a small-field digital mammographic imaging system composed of a CCD (charge coupled device) detector and an X-ray source coupled with parabolic polycapillary optics. The spatial resolution and radiation dose according to various filters were evaluated for a small-field digital mammographic imaging system. The images of a test standard phantom and breast cancer tissue sample were obtained. RESULTS: The small-field digital mammographic imaging system had spatial resolutions of 12 lp/mm with molybdenum and rhodium filters with a 25-micrometer thickness. With a thicker molybdenum filter (100 micrometer thick), the system had a higher spatial resolution of 11 lp/mm and contrast of 0.48. The radiation dose for a rhodium filter with a 25-micrometer thickness was 0.13 mGy within a 10-mm-diameter local field. A larger field image greater than 10 mm in diameter could be obtained by scanning an object. On the small-field mammographic imaging system, microcalcifications of breast cancer tissue were clearly observed. CONCLUSION: A small-field digital mammographic imaging system with parabolic polycapillary optics may be a useful diagnostic tool for providing high-resolution imaging with a low radiation dose for examination of local volumes of breast tissue.
Equipment Design ; Humans ; Mammography/*instrumentation ; Molybdenum ; Optics and Photonics/*instrumentation ; Phantoms, Imaging ; Radiographic Image Enhancement/*instrumentation ; Rhodium

OBJECTIVETo compare the effectiveness of full-field digital mammography (FFDM) and magnetic resonance imaging (MRI) in the detection and diagnosis of breast diseases.

METHODSForty-one patients with 47 breast lesions (20 malignant and 27 benign lesions) underwent preoperative FFDM and MRI, using the pulse sequences including T1WI, T2WI, T2WI/SPIR diffusion-weighted imaging (DWl), and 3D dynamic contrast-enhanced MRI.

RESULTSThe imaging and pathological findings were compared, and the detection rates of the lesions by FFDM and MRI were 97.87% (46/47) and 74.46% (35/47), respectively (P<0.01). The sensitivity of FFDM and MRI was 70.00% (14/20) and 80.00% (16/20) (P>0.05), with specificity of 62.96%(17/27) and 88.89%(24/27) (P<0.05), respectively.

CONCLUSIONMRI is superior to FFDM in the detection and diagnosis of breast diseases.

Adenoma ; diagnosis ; Adult ; Breast Neoplasms ; diagnosis ; Carcinoma, Ductal, Breast ; diagnosis ; Female ; Humans ; Magnetic Resonance Imaging ; Mammography ; instrumentation ; methods ; Middle Aged ; Radiographic Image Enhancement ; Sensitivity and Specificity ; Young Adult

OBJECTIVETo summarize the morphological features of basal-like subtype of invasive breast carcinoma (BLSIBC), and to look for diagnostic clues for its recognition.

METHODSImmunohistochemistry was performed in 109 cases of invasive ductal carcinoma, with CK5/6, CK14, CK8/ 18, 34betaE12, calponin, p63, CD10, ER, PR and c-erbB-2 monoclonal antibodies. Five subtypes were classified according to immunophenotypes: luminal A subtype (ER+/HER2-), luminal B subtype (ER+/ HER2+), normal breast-like subtype (ER/HER2-), HER2-overexpressing subtype and BLSIBC which was identified with at least one kind of basal-like cytokeratins or markers of myoepithelium and ER/HER2. The microscopic features of basal-like subtype were also analyzed.

RESULTSThe number of luminal A case was 48 (44.0%), luminal B 15 (13.8%), HER2 over-expressing 15 (13.6%), normal breast-like 10 (9.1%), basal-like subtype 19 (17.4%). Besides, the other two cases expressed c-erbB-2 or/and ER plus markers for myoepithelium, thus were excluded from all the five mentioned subtypes. Of the 19 basal-like subtype, CK5/6 was expressed in 16 cases, CK8/18 in 17 cases, CK14 in 11 cases, 34betaE12 in 18 cases, p63 in 5 cases, CD10 in 6 cases, and calponin in 1 case. The diameter of the BLSIBC cases was 1.2-7 cm (averagely 3.9 cm) , and in 6 cases, the tumor diameter was >5 cm. Only one case displayed extensive in situ component, 9 cases were grade 2, and 9 cases were grade 3. Compared to non basal subtype, there were significantly more high grade cases (P <0.01). The morphological features of basal-like subtype were summarized as the followings: pushing margin (13 cases), lymphocytic tissue hyperplasia (18 cases), nest or sheet arrangement (18 cases), nucleus grade 3 and scattered giant or bizarre nuclei (17 cases), syncytial growth (7 cases), and comedo-like necrosis (17 cases). The frequency of these features were significantly more common than non basal subtype (P <0.01).

CONCLUSIONThe morphologic diagnostic features of BLSIBC are pushing margins, lymphocyte infiltration, comedo-like necrosis, gigantic cell and syncytial growth.

Biomarkers, Tumor ; analysis ; Breast Neoplasms ; diagnosis ; pathology ; Carcinoma, Basal Cell ; pathology ; Female ; Genes, erbB-2 ; physiology ; Humans ; Immunohistochemistry ; Keratin-5 ; analysis ; Magnetic Resonance Imaging ; Male ; Mammography ; instrumentation ; methods ; Neoplasm Invasiveness ; physiopathology ; Prognosis ; Receptor, Epidermal Growth Factor ; genetics ; Receptor, ErbB-2 ; analysis ; genetics ; Receptors, Estrogen ; analysis ; Receptors, Progesterone ; analysis ; Ultrasonography ; methods

OBJECTIVETo evaluate fine needle localized biopsy under mammography-guiding and skin incision selection by hookwire under ultrasound-guiding for patients with breast microcalcification.

METHODSBreast microcalcification of 178 patients treated from May 2000 to November 2006 were resected after localized with fine needle under X-ray mammography-guiding. Among them, 62 patients received the selection of hookwire under ultrasound-guiding.

RESULTSBreast cancer was detected in 58 patients (32.6%). Among them, 32 (55.1%) cases were carcinoma in situ, 11 (19.0%) intraductal carcinoma with early infiltration, 15 (25.9%) infiltrative ductal carcinoma, and 4 infiltrative ductal carcinoma with lymph node metastasis. The overall 5-year survival rate was 100%. Compared with that in needle guided group, the acceptable rate of cosmetic results was higher in hookwire group (P = 0.022).

CONCLUSIONSFor breast microcalcification, mammography guided needle biopsy with ultrasound selected skin incision is an effective and accurate diagnostic method.

Adult ; Aged ; Biopsy, Needle ; instrumentation ; methods ; Breast ; pathology ; Breast Diseases ; pathology ; Breast Neoplasms ; pathology ; Calcinosis ; diagnosis ; Diagnosis, Differential ; Female ; Follow-Up Studies ; Humans ; Mammography ; Middle Aged ; Reproducibility of Results ; Sensitivity and Specificity ; Stereotaxic Techniques ; Ultrasonography, Mammary