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临床试验/EUCTR2020-000819-67-GB
EUCTR2020-000819-67-GB进行中(未招募)1 期

SENTINUS: Technical feasibility and diagnostic accuracy of intradermal microbubbles and contrast enhanced ultrasound to identify sentinel lymph node metastases in breast cancer patients following training and mentorship of imaging specialists - SENTINUS

Maidstone and Tunbridge Wells NHS Trust0 个研究点目标入组 250 人开始时间: 2020年6月10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)
入组人数
250

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
Female

入选标准

  • Histologically confirmed invasive carcinoma of the breast without palpable axillary lymph nodes with planned
  • primary surgical treatment.
  • Normal B-mode axillary ultrasound or benign biopsy of morphologically abnormal lymph nodes.
  • Participant is willing and able to give informed consent for participation in the trial.
  • Aged 18 years or above.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 175
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 75

排除标准

  • Previous ipsilateral breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer.
  • Female participant who is pregnant, lactating or planning fertility preservation during the course of the
  • Allergy to contrast.
  • Inflammatory or locally advanced breast cancer.
  • Metastatic breast cancer.
  • Inability to raise ipsilateral arm above head.
  • Multiple medical co-morbidities (ASA 4 or above).
  • Previous ipsilateral axillary surgery.

研究者

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