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临床试验/NCT05161507
NCT05161507已完成不适用

Targeted Axillary Dissection, Sentinel Biopsy, and Tumor Lesion Localization in Breast Cancer Patients Using the New Magnetic "Sentimag" Detection System

University Hospital Ostrava1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年5月4日最近更新:
适应症

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

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

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (1)

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