DRKS00023954尚未招募未知
Motion-model Ultrasound Localization Microscopy (mULM) for Diagnostics and Therapy Monitoring in Breast Carcinoma
Klinik für Gynäkologie und Geburtshilfe RWTH Aachen0 个研究点目标入组 74 人开始时间: 2021年1月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- Female
入选标准
- •1. patients with histologically confirmed primary breast carcinoma including all intrinsic subtypes (study part A and B) and patients with high-grade suspicion of primary breast carcinoma (study part C).
- •2. treatment with neoadjuvant chemotherapy (study part A and B)
- •3. written informed consent
- •4. subjects who are legally competent and mentally able to comply with the instructions of the study personnel
排除标准
- •1. minority
- •2. hypersensitivity / allergy to ultrasound contrast agent or its components sulfur hexafluoride, macrogol 4000, colfosceril stearate, 1-(1,2-dipalmitoyl-3-sn-phosphatidyl)glycerol sodium salt palmitic acid
- •3. right-left shunt
- •4. signs of cardiovascular instability
- •5. acute endocarditis
- •6. artificial heart valves
- •7. acute systemic inflammation and/or sepsis
- •8. overactive coagulation status and/or recent thromboembolism
- •9. end-stage renal or hepatic disease
- •10. severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHG)
- •11. uncontrolled systemic hypertension
- •12. acute respiratory distress syndrome
- •13. pregnant women
- •14. persons who are institutionalized by administrative or judicial order
- •15. persons who are in a dependent or employment relationship with the sponsor or investigator
- •16. alcohol and drug abuse
- •17. expected non-compliance
研究者
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