DRKS00015067已完成不适用
Clinical Evaluation of High-resolution, Contrast-enhanced Low-dose Breast-CT (Sub-study I) - Breast-CT (Sub-study I)
Klinik für Diagnostische und Interventionelle Radiologie, Uniklinik RWTH Aachen0 个研究点目标入组 65 人开始时间: 2019年7月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40 Years 至 one（—）
- 性别
- Female
入选标准
- •Sub-project A (Finished):
- •1) Women in either BI-RADS 6 situation (i.e. already biopsy proven breast cancer), or women who, based on conventional Imaging, exhibit a lesion
- •categorized as BIRADS-5 (i.e. a high likelihood of breast cancer) (tested value not older than 8 weeks).
- •2) Women with normal renal function (MDRD with GFR >= 60 ml/min/1,73m2).
- •3) Women with normal thyroid function as evidenced by a clinically unobstrusive TSH value.
- •4) Women who are able to provide informed written consent and are aware of the nature, meaning and extent of the study. 3) Women who provided this written informed consent.
- •Sub-project B:
- •1) Same as for sub-project A.
- •2) Women with non-malignant lesions as defined as being categorized as BI-RADS 4 by conventional imaging-findings.
排除标准
- •For sub-project A+B:
- •1) Women not fulfilling the inclusion criteria.
- •2) Pregnant or breastfeeding women.
- •3) Women in child-bearing age without sufficient contraception.
- •4) Women less than 40 years of age.
- •5) Women with a body weight larger than 135 kg.
- •6) Women with proven pathogenic Breast Cancer (BRCA) 1-mutation or risk of BRCA1-heterozygosity >= 25%.
- •7) Terminal or advanced renal insufficiency (GFR < 60 ml/min/1,73 m2).
- •8) Clinical or laboratory signs of an endocrine autonomy (TSH suppression).
- •9) Known allergies or intolerances grade II or higher for iodinated contrast agents (Iopromide).
- •10) Hospitalization was ordered by court or local authorities.
- •11) Relationship of dependence or employment to sponsor or investigator.
- •12) Simultaneous participation in another clinical trial.
- •13) Being unwilling to follow the instructions of the investigator.
- •14) Women who lack the mental ability or capacity to understand the explanations and the nature of the study as well as its meaning, aims and focus.
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