Diffusion Magnetic Resonance Imaging in Mamographically Detected Asymmetric Densities
赞助:
Assiut University
合作者:
信息的提供 (责任方):
Shimaa Ali Saad，Assiut University
| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 3, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | October 1, 2018 | ||
| 预计主要完成日期 | July 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Comparison of diffusion MRI finding with the pathology of the specimens[ Time Frame: Baseline ] Analysis of diffusion weighted images and ADC values to defferntiate different pathologies causing asymmetric densities in routine screening or diagnostic mammography |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Diffusion Magnetic Resonance Imaging in Mamographically Detected Asymmetric Densities | ||
| 正式标题 ICMJE | Role of Diffusion Magnetic Resonance Imaging in Assessment of Mammographically Detected Asymmetric Densities | ||
| 简要概况 | The aim of the study is to identify the role of diffusion weighted MRI in the assessment of the clinical significance and outcomes of asymmetric breast densities identified on mammograms, and to identify the inconclusive mammographic findings most frequently associated with occult breast carcinoma. |
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| 详细说明 | Although there is clearly a wide variation in breast size and parenchymal pattern, the breasts are generally symmetric structures with similar density and architecture. However, asymmetric breast tissue is encountered relatively frequently. Asymmetric breast tissue is usually benign and secondary to variations in normal breast tissue, postoperative change from a previous biopsy, hormone replacement therapy , or merely poor positioning. However, an asymmetric area may indicate a developing mass or an underlying cancer. The American College of Radiology (ACR), Breast Imaging Reporting and Data System (BI-RADS) defined four different types of asymmetric breast findings: 1. Asymmetric Breast tissue: refers to a greater volume or density of breast tissue in one breast than in the corresponding area in the contra lateral breast. 2. Densities seen in one projection: reflect a density seen in only one mammographic projection. 3. Architectural distortion: refers to a focal area of breast tissue that appears distorted with no definable central mass. Speculations radiate from a common point, and there is an area of focal retraction and tethering of normal parenchyma. 4. Focal asymmetric densities: refer to focal asymmetric densities that are seen on two mammographic views but cannot be accurately identified as a true mass. These lesions are frequently encountered at screening and diagnostic mammography and are significant because they may indicate a neoplasm, especially if an associated palpable mass is present. Once these lesions are detected at standard mammography, supplementary breast imaging with additional mammographic views and ultrasonography (US) can be a key aspect of work-up. However, these techniques may be insufficient to make a final BI-RADS assessment and may have limited sensitivity and specificity for the detection and diagnosis of breast lesions, yielding equivocal results. Certainty of the presence or absence of a true lesion can be difficult, and the findings remain inconclusive. Moreover, Architectural distortion should always be regarded with suspicion but differentiation from summation artifact is problematic. Developing asymmetric densities need to be evaluated unless they can be explained in terms of benign causes. In these situations, MRI can be performed as an additional problem- solving procedure. Positive MRI examination will prompt biopsy and allow for the timely detection of malignancies that may otherwise would gone undiagnosed, while a negative MRI will allow increased confidence that the equivocal finding was likely caused by summation artifact or benign tissue , so follow-up surveillance mammography without biopsy will be undergone. Although conventional breast MRI has a high sensitivity (89-100%) in the characterization of breast lesions . However, an overlap between benign and malignant findings still persists, resulting in a variable specificity (50-90%). The DWI derives images from the difference of water molecules motion (Brownian motion) in tissues, resulting in quantitative and qualitative data reflecting changes at the cellular level and, consequently, unique information on the tumor cellularity and cell membranes integrity. This would allow the increase in breast MRI specificity and reduction of false-positive results and unnecessary biopsies. Cell density might play an important role in the different ADCs obtained from benign and malignant breast lesions and the measurement of extracellular water content may be an additional feature that can improve MRI specificity. The main objectives in using diffusion sequences are to optimize characterization of lesions differentiating benign from malignant tumors; and to improve detection of small lesions, which requires an optimal signal-to-noise ratio. several authors have shown that this technique is relevant for smaller masses (5 mm) and even for non-mass like enhancements. | ||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
50 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 2019 | ||
| 预计主要完成日期 | July 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - All patients presented with asymmetric breast densities, seen on screening or diagnostic mammograms. Exclusion Criteria: - Patients with cardiac pacemakers. - Patients with brain aneurysm clips. - Patients with cochlear implants. - Patients with vascular stents. - Claustrophobic. | ||
| 性别 |
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| 年龄 | 最小年龄：20 Years ，最大年龄：80 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Shimaa Ali Saad，Assiut University | ||
| 研究赞助商 ICMJE | Assiut University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Assiut University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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