EUCTR2018-004389-33-FI进行中(未招募)1 期
Contrast enhanced ultrasound a novel technique in lymphatic imaging – A Prospective study
Olli Lahtinen0 个研究点目标入组 160 人开始时间: 2020年5月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1st branch: 50 healthy volunteers with no prior upper arm surgery
- •2nd branch: 50 consecutive patients with known history of breast cancer or upper arm melanoma with possible known lymphedema.
- •3rd branch: 30 patients with prior history of breast cancer and possible lymphedema. All consecutive breast cancer patients having traditional lymphoscintigraphy as a part of their standard imaging are also recruited for this branch.
- •4th branch: 30 consecutive patients with newly diagnosed vulvar cancer to whom sentinel biopsy will be scheduled.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1) Vulvar carcinoma patients who won’t have traditional lymphoscintigraphy (branch 4) 2) Vulvar carcinoma patients with prior lymphadenectomy in the groin area (branch 4) 3) People with egg allergy (all branches) 4) Patients to whom gadolinium contrast agent is contraindicated (branch 3) 5) Patients who have claustrophobia and can’t enter the MRI (branch 3). 6) Patients who have foreign material in their body which is contraindicated for MRI
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