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临床试验/NCT04136496
NCT04136496撤回不适用

Evaluation of a Novel Axillary Lymph Node Ink Localization Technique: A Feasibility Study

The Ottawa Hospital2 个研究点 分布在 1 个国家开始时间: 2020年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Identification rate of Inked nodes, not containing clip

研究概览

简要总结

Patients with breast cancer and metastatic axillary lymphadenopathy routinely undergo neo-adjuvant chemotherapy. For these patients, biopsy clip markers are inserted into the biopsy proven metastatic lymph node pre-treatment, as they may reach complete clinical response post-therapy. Limited axillary surgery, as opposed to a full axillary dissection, may then be indicated. It is still necessary to surgically excise the biopsy proven metastatic lymph node to accurately assess the pathologic response to therapy, and subsequently tailor post-surgical therapies appropriately. As such, these lymph nodes require pre-operative localization which, at The Ottawa Hospital, currently requires radioactive seed insertion under sonographic guidance, typically performed within 5 days of surgery. The procedure is often challenging, as both normal appearing lymph nodes and 3 mm biopsy clip markers are difficult and in some cases impossible, to visualize on ultrasound. At the time of surgery, the excised lymph node is radiographed, to ensure the radioactive seed and biopsy clip marker are both successfully excised. Localization with Ink has the potential to replace both the biopsy clip markers and radioactive seeds as the surgeons are able to directly visualize the Ink intra-operatively and excise the Inked lymph node. A preliminary study out of Stanford on 28 patients who underwent localization of axillary lymph nodes with Ink injected 1-211 days pre-operatively, in the pre neo-adjuvant and post neo-adjuvant settings, showed that lymph nodes injected with Ink are visible intra-operatively months after surgery, suggesting that this is a feasible localization technique (1).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English or French speaking female patients, with a personal history of current pathologically proven breast cancer, over the age of 18 years [patients <18 would be considered a rare occurrence]
  • Patients who will be undergoing neoadjuvant chemotherapy
  • Patients who will be undergoing axillary lymph node radioactive seed localization
  • Patients who will be undergoing axillary surgery

排除标准

  • Allergic reaction to Black Eye Ink or any of its components
  • Pregnancy
  • Confirmed metastatic disease

结局指标

主要结局

Identification rate of Inked nodes, not containing clip

时间窗: 3 years

Identification rate of Inked nodes, containing seed and clip

时间窗: 3 years

Identification rate of Inked nodes, not containing seed

时间窗: 3 years

Identification rate of Inked nodes, not containing seed or clip

时间窗: 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Raman Verma

Principal Investigator

The Ottawa Hospital

研究点 (2)

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