中文(简体)
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Carbon Dye Tattooing of Biopsied Axillary Node in Breast Cancer

只有注册用户可以翻译文章
登陆注册
链接已保存到剪贴板
状态已完成
赞助商
University Hospitals of Derby and Burton NHS Foundation Trust

关键词

抽象

The primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. The secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing ALND after NACT).

描述

Pretreatment evaluation of axillary lymph nodes and marking of biopsied nodes in patients with newly diagnosed breast cancer is becoming routine practice. Tagging of biopsied axillary lymph nodes with metal markers, similar to what is done for suspicious breast lesions, is being adopted in clinical practice. The need to mark a positive axillary lymph node becomes especially relevant in cases where neoadjuvant chemotherapy (NACT) is anticipated so that these nodes may be identified at the time of surgery. Measures that improve both the accuracy of nodal evaluation after NACT and the ability to assess treatment response are desirable in order to tailor therapies for breast cancer treatment. The investigators sought to test tattooing of biopsied axillary lymph nodes with a sterile black carbon suspension (Spot dye). The concept is based on the experience in the gastrointestinal tract wherein tattooing is widely used for marking lesions or tumours biopsied during endoscopy. India ink tattoos of colonic lesions remain identifiable over a long period of time. Spot is routinely used in the UK for tattooing gastrointestinal tract lesions and is used to mark the axillary lymph nodes in breast cancer by some centres in the US and Europe. The intraoperative success of identifying tattooed axillary lymph nodes and their concordance to sentinel nodes will be determined.

日期

最后验证: 05/31/2020
首次提交: 08/14/2018
提交的预估入学人数: 08/16/2018
首次发布: 08/20/2018
上次提交的更新: 06/28/2020
最近更新发布: 06/30/2020
实际学习开始日期: 04/26/2018
预计主要完成日期: 07/30/2019
预计完成日期: 07/30/2019

状况或疾病

Sentinel Lymph Node
Breast Cancer
Tattoo; Pigmentation
Axilla; Breast

干预/治疗

Procedure: Tattooing of biopsied node

-

手臂组

干预/治疗
Experimental: Tattooing of biopsied node
The biopsied node will be tattooed at the time of needle biopsy (fine needle aspiration or core biopsy) or separate visit under ultrasound guidance.
Procedure: Tattooing of biopsied node
Tattooing (marking) of biopsied node with carbon dye (SPOT dye) at the time of fine needle aspiration or core biopsy or separate visit under ultrasound guidance. The dye will be injected in the cortex of the node and the perinodal tissue under ultrasound guidance. Patients will undergo standard (routine) armpit surgery and may receive neoadjuvant chemotherapy as planned by the clinical team. This could be removal of a few lymph glands (sentinel node biopsy) or removal of all the lymph glands (axillary lymph node dissection) in the armpit. The surgeon will try to identify and remove the tattooed lymph gland at the time of planned armpit surgery.

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

- Age ≥ 18

- Male or female

- Patients scheduled to undergo routine fine needle aspiration (FNA) or core biopsy of abnormal axillary lymph node

- Invasive breast cancer

- Written informed consent for the study

Exclusion Criteria:

- Not undergoing surgery or unfit for surgery

结果

主要结果指标

1. Identification rate of tattooed node [12 months]

Proportion of patients in whom tattooed node/s were identified.

次要成果指标

1. Concordance of tattooed node and sentinel node [12 months]

Concordance rate: defined as the percent of patients in whomthe tattooed node is the sentinel node.

2. Migration of black dye into other nodes [12 months]

The number of black nodes at the time of sentinel node biopsy or axillary lymph node dissection.

加入我们的脸书专页

科学支持的最完整的草药数据库

  • 支持55种语言
  • 科学支持的草药疗法
  • 通过图像识别草药
  • 交互式GPS地图-在位置标记草药(即将推出)
  • 阅读与您的搜索相关的科学出版物
  • 通过药效搜索药草
  • 组织您的兴趣并及时了解新闻研究,临床试验和专利

输入症状或疾病,并阅读可能有用的草药,输入草药并查看所使用的疾病和症状。
*所有信息均基于已发表的科学研究

Google Play badgeApp Store badge