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临床试验/DRKS00023954
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

发起方
Klinik für Gynäkologie und Geburtshilfe RWTH Aachen

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