Evaluation of the High-resolution, Contrast Enhanced Low-dose Breast-CT
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- Sub-Study 1: comparison of a-posteriori sensitivity using the native, contrast-enhanced or dynamic contrast-enhanced breast CT.
研究概览
简要总结
The aim of this study is the clinical establishment of a native and contrast-enhanced computer tomography of the breast. The early detection of breast cancer is still a great challenge. Even though the implementation of the digital mammography combined with the mandatory screening-programs lead to significant improvements, sensitivity and specificity of these examinations need to be clearly classified as improvable. Generally, it is stated that the necessary transit from 2-D projected images to 3-D tomography will be crucially advantageous as magnetic resonance imaging has already shown. Similar or even major advantages can be expected by new approaches regarding CT with very high local resolution, better than 100µm in 3D and lower dose, under 5 Milligray (mGy), as demanded for a screening. A device that meets these demands and is also applicable for dynamic scans after intravenous administration of a contrast agent, has been developed with the support by the European Union (EU), German Research Foundation (DFG) and Federal Ministry of Education and Research (BMBF). Publications on technical and experimental results are already available. An evaluation in the clinical use is missing yet. The primary aim of this study is to evaluate systematically the performance of the native and dynamic, contrast-enhanced CT of the breast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sub Study 1:
- •patients with mammographic or sonographic validated Breast Imaging Reporting and Data System (BI-RADS)-4 or BI-RADS-5-result or in BI-RADS-6-situation, i.e. with an already reliable carcinoma by punch biopsy, for which a clinical indication for a mamma-MRI consists.
- •Age >= 40
- •maintained renal function (MDRD with GFR >= 60 ml/min/1,73m²)
- •normal thyroid function, no clinical indication for an endocrine autonomy, normal TSH (not older than 8 weeks)
- •Persons which are able to give written consent and are aware of the nature, meaning and extent of the study
- •signed informed consent
- •Substudy 2:
- •patients with a doubtful and suspect clinical or mammographic or sonographic result (BI-RADS 3, 4a, 4b, 4c, 5) as well as patients with a reliable carcinoma by punch biopsy (BI-RADS 6), patients with high risk of breast cancer for which a clinical indication for a mamma-MRI consists.
- •Age >= 40
- •maintained renal function (MDRD with GFR >= 60 ml/min/1,73m²)
- •normal thyroid function, no clinical indication for an endocrine autonomy, normal TSH (not older than 8 weeks)
- •Persons which are able to give written consent and are aware of the nature, meaning and extent of the study
- •signed informed consent
排除标准
- •Substudy 1:
- •Pregnancy or lactation
- •Women with child-bearing potential without sufficient contraception
- •Age <40 years
- •Women with proven pathogenic Breast Cancer (BRCA) 1-mutation or heterozygote risk (>= 25%)
- •Hospitalization of patient ordered by the court or local authorities
- •Relationship of dependence or employment to sponsor or investigator
- •additionally the following criteria apply, if conducting the dynamic contrast-enhanced breast-CT
- •signs of a renal insufficiency (GFR < 60ml/min/1,73m²)
- •clinical signs or signs of the labor chemistry for endocrine autonomy (increase of TSH)
- •Patients with known allergies or intolerance reactions grade II or higher to contrast medium containing iodine
- •Substudy 2:
- •Pregnancy or lactation
- •Women with child-bearing potential without sufficient contraception
- •Age <40 years
- •Women with proven pathogenic BRCA 1-mutation or heterozygote risk (>= 25%)
- •Hospitalization of patient ordered by the court or local authorities
- •Relationship of dependence or employment to sponsor or investigator
- •additionally the following criteria apply, if conducting the dynamic contrast-enhanced breast-CT:
- •end stage or advanced renal insufficiency
- •clinical signs or signs of the labor chemistry for endocrine autonomy (increase of TSH)
- •Patients with known allergies or intolerance reactions grade II or higher to contrast medium containing iodine
结局指标
主要结局
Sub-Study 1: comparison of a-posteriori sensitivity using the native, contrast-enhanced or dynamic contrast-enhanced breast CT.
时间窗: 2 years
By using the images diagnostic criteria for identification and characterization of the pathologic and physiologic changes of the female breast will be elaborated.
次要结局
- Substudy 2: Positive Predictive Value (PPV) of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures(2 years)
- Comparison of biological value of the diagnosed carcinoma in dependence with its detection mode.(2 years)
- Sub-study 2: specificity of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures(2 years)
- Substudy 2: sensitivity of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures(2 years)
- Substudy 2: Negative Predictive Value (NPV) of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures(2 years)