A Prospective, Open Label Study of the Use of Magseed® and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-Proven Metastases in Breast Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This phase IV trial studies the side effects of the Magseed magnetic marker and how well it works in locating lymph nodes in the underarm area in patients with breast cancer undergoing surgery. Injecting a small metallic marker in or near the lymph node prior to surgery may help the surgeon locate the lymph nodes during surgery without using radiation.
详细描述
PRIMARY OBJECTIVE:
I. To provide evidence that the clipped lymph node and Magseed can be successfully retrieved in the excised surgical specimen when Magseed and Sentimag are used for targeted axillary dissection in breast cancer patients.
OUTLINE:
Patients receive the Magseed marker via ultrasound guided injection into the previously clipped lymph node or within perinodal tissue =< 3 mm from the clipped node. Patients then undergo axillary lymph node localization and targeted dissection within 30 days.
After completion of study, patients are followed up within 6-22 days post-surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •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 completing chemotherapy
- •Received neoadjuvant chemotherapy prior to surgical resection
- •Scheduled for targeted axillary dissection (defined as selective localization and removal of the clipped node and sentinel lymph node dissection [SLND])
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
排除标准
- •Distant metastases
- •Inflammatory breast cancer
- •Prior surgical axillary procedure including SLND or axillary node excision
- •Prior history of breast cancer in the ipsilateral breast
- •History of lymphoma
- •The subject is known to be pregnant. Premenopausal patients under the age of 50 must have a pregnancy test performed as standard of care before the MagSeed is placed
- •Previous radiation to the breast or axilla
- •Pacemaker of other implantable device in the chest wall
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 6 weeks post-procedure
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity data will be summarized by frequency tables. For the toxicity endpoint, per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.
Retrieval rate
时间窗: Up to 15 months
Will be 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. For the analysis of retrieval rate, if the trial is not stopped early and all 50 patients are accrued, then point estimate along with 95% credible interval will be provided. Logistic regression model will be utilized to assess the association of patient demographic and clinical factors with the retrieval.
次要结局
- Accuracy of Magseed placement(Up to 15 months)
- Surgeon rated ease of node localization and removal(Up to 15 months)
- Transcutaneous detection rate(Up to 15 months)
- Radiologist rated ease of Magseed placement(Up to 15 months)
- Number of nodes retrieved within the surgical specimen containing the Magseed(Up to 15 months)