Targeted Axillary Dissection, Sentinel Biopsy, and Tumor Lesion Localization in Breast Cancer Patients Using the New Magnetic "Sentimag" Detection System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Accuracy of Magseed placement
研究概览
简要总结
The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy.
详细描述
The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. It also aims to follow skin discoloration after Magtrace injection and describe when and how it resolves. The Magtrace will be injected preoperatively. Sentinel node biopsy will be performed and detection rates will be recorded for both methods.
The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Intraoperative localization of the seed is achieved with the use of the Sentimag probe.
Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy. To accurately assess the response in the breast and the axilla, it is important that both the positive lymph node/s are marked before neoadjuvant systemic therapy to be able to locate them later on. Systemic therapy can negatively impact lymphatic drainage and hence reduce the accuracy of the sentinel lymph node biopsy (SLNB). However, when SLNB is paired with the removal of the previously positive target lymph node, a technique called Targeted Axillary Dissection, the operation becomes a lot more accurate, with lower morbidity of the patients.
A part of the study is also the verification of the time stability of breast tumor labeling with Magseed in the period from the onset of neoadjuvance to the subsequent operation following the oncological pretreatment of the patient.
All patients will undergo sentinel lymph node detection also by the classic detection system with Tc99.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 breast cancer
- •Without/ With axillary lymph node metastasis with pathologic confirmation by needle biopsy
- •With/ without received neoadjuvant chemotherapy prior to surgical resection
排除标准
- •Distant metastases
- •The subject is known to be pregnant
- •Pacemaker of another implantable device in the chest wall
- •Allergy to dextran or other iron-containing particles
结局指标
主要结局
Accuracy of Magseed placement
时间窗: During the surgical procedure
Accuracy of Magseed placement will be measured regarding its position towards the lymph node in mm. Will be defined as accurate, marginal or inadequate. Descriptive statistics will be used to summarize accuracy of placement. Other statistical methods, when appropriate, may be used for analysis.
Number of nodes retrieved within the surgical specimen containing the Magseed
时间窗: During the surgical procedure
Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed.
Transcutaneous detection rate
时间窗: During the surgical procedure
Descriptive statistics will be used to summarize transcutaneous detection rate.
Surgeon-rated ease of detected lymph node localization and removal
时间窗: During the surgical procedure
Descriptive statistics will be used to summarize surgeon rated ease of localization.
Surgeon-rated ease of detected labeled lesion localization and removal
时间窗: During the surgical procedure
Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed.
Incidence of adverse events
时间窗: Up to 6 weeks post-procedure
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.
次要结局
未报告次要终点
