A Prospective Open Label Study of the Use of Magseed® Markers and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-proven Metastases in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Retrieval rate of clipped node and Magseed in the excised specimen
研究概览
简要总结
The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (NAC) is effective.
详细描述
This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag system during surgery and removed with the targeted lymph node.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Age 18 years or older at time of consent
- •Histologically confirmed cT0-4, N1 breast cancer
- •Axillary lymph node metastasis with pathologic confirmation by needle biopsy
- •Clip placed in the sampled axillary lymph node before initiation of chemotherapy
- •Planned for neo-adjuvant chemotherapy prior to surgical resection
- •Eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy
- •ECOG performance status 0-2
排除标准
- •Distant metastases
- •Inflammatory breast cancer
- •Prior ipsilateral axillary surgical procedure including SLND or axillary node excision
- •Prior history of breast cancer in the ipsilateral breast
- •History of lymphoma
- •Subject is pregnant
- •Previous radiation to the breast or axilla
- •Pacemaker or other implantable cardiac device in the ipsilateral chest wall
结局指标
主要结局
Retrieval rate of clipped node and Magseed in the excised specimen
时间窗: Time of surgery
The retrieval rate of the clipped node and Magseed in the excised specimen. This is defined as the number of subjects in whom the clipped node and Magseed are retrieved in a single excised specimen divided by the total number of subjects.
次要结局
- Radiologic placement accuracy(Between completion of NAC time of surgery)
- Radiologic rated ease of Magseed placement(Time of Magseed marker placement)
- Radiologic seed position(After completion of NAC)
- Surgical nodes localized(Time of surgery)
- Ease of surgical localization(Time of surgery)
- Rates of device and serious device-related events(Up to 42 days post-surgery)