Targeted Axillary Dissection Using Carbon Marking for Patients With Node-positive Breast Cancer Following Neoadjuvant Therapy (TADCOM): a Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Lymph node retrieval rate marked
研究概览
简要总结
This study evaluates the efficacy and feasibility of Carbon Nanoparticle Suspension Injection (CNSI) for Targeted Axillary Dissection (TAD) in breast cancer patients undergoing neoadjuvant chemotherapy (NAC), compared to traditional clip-based methods. By leveraging CNSI's enhanced visibility and stability, the study aims to improve the precision of lymph node removal, reduce surgical complications, and potentially transform clinical practices. Conducted across multiple centers, this randomized controlled trial focuses on clinical outcomes such as lymph node retrieval rates and the accuracy of surgical staging, aiming to establish a safer, more effective approach to managing axillary lymph nodes in breast cancer surgery.
详细描述
Objective: This study aims to assess the clinical feasibility, accuracy, and effectiveness of CNSI in targeted axillary dissection compared to traditional tissue marker clips in patients with breast cancer undergoing neoadjuvant chemotherapy (NAC).
Background: Breast cancer remains one of the most prevalent cancers among women globally. Neoadjuvant chemotherapy (NAC) has significantly advanced the management of locally advanced breast cancer, enabling more conservative surgical approaches and reducing the dependency on axillary lymph node dissection (ALND), which is often associated with long-term complications such as lymphedema and chronic pain. Traditional TAD methods using tissue marker clips have challenges including high costs and potential for marker loss. CNSI presents a novel approach with potential for enhanced surgical precision and reduced complication rates.
Methods: The study employs a multicenter, randomized controlled trial design to compare the outcomes of TAD using CNSI versus conventional clip-based methods. Patients with clinically node-positive breast cancer who achieve clinical node-negative status post-NAC are enrolled. The primary endpoints include the rate of successful lymph node retrieval, the incidence of surgical complications, and the accuracy of lymph node staging.
Innovation: CNSI is designed to improve the visibility and stability of lymph nodes during surgery, potentially increasing the precision of cancerous node removal and minimizing the need for subsequent surgical interventions. Its unique properties, such as the slow metabolic rate and strong pigmentation, ensure prolonged visibility and facilitate easier identification during surgery.
Significance: By enhancing the effectiveness of TAD, CNSI could transform clinical practices in breast cancer surgery, reducing the physical burden of surgery and improving the quality of life for patients. The study's findings could lead to broader adoption of CNSI in surgical oncology, setting a new standard for axillary management in breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer with axillary lymph node metastasis confirmed by puncture pathology (T1-3N1M0)
- •accord with the indications of neoadjuvant chemotherapy for breast cancer
- •informed consent has been signed
- •Preoperative anesthesia assessment is low to medium risk (ASA score)
排除标准
- •There are absolute and relative contraindications of chemotherapy
- •Refuse surgery or can't tolerate surgery
- •Unable to cooperate or unwilling to place Marker
- •Pregnant women
- •Do not have full capacity for behavior, such as mental patients, drug dependence, anxiety and so on
- •Diabetes patients who are difficult to control
- •Excessive smokers
- •high risk of anesthesia
- •Any serious complications are not suitable for patients participating in this study
研究组 & 干预措施
Group 1: CG-TAD Group
US-guided clip insertion into suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and clipped LNs
干预措施: Tissue Marker Clip (Device)
Group 2: CN-LNM Group
US-guided CNSI injection to tattoo suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and carbon-marked LNs
干预措施: Carbon Nanoparticle Suspension Injection (Drug)
Group 3: PCN-MAP Group
US-guided CNSI injection around primary tumor pre-NAC, additional US-guided clip placement for metastatic LN Post-NAC, TAD removing SLNs, carbon-marked LNs, and clipped LNs
干预措施: Carbon Nanoparticle Suspension Injection (Drug)
结局指标
主要结局
Lymph node retrieval rate marked
时间窗: Up to 2 months
The proportion of successfully retrieved marked lymph nodes will be calculated and compared among the study groups to evaluate the effectiveness of each marking technique.
Number of sentinel and marked lymph nodes
时间窗: Up to 2 months
The mean, median, and range of the number of sentinel and marked lymph nodes harvested during surgery will be recorded and compared to assess the efficacy of the marking techniques in identifying lymph nodes of interest.
Concordance between marked and sentinel lymph nodes
时间窗: Up to 2 months
The consistency between marked lymph nodes and intraoperatively identified sentinel lymph nodes will be evaluated by calculating the percentage of marked nodes that are also sentinel nodes and vice versa.
Complication rate
时间窗: Up to 60 months
All surgery-related complications, including but not limited to hemorrhage, lymphedema, infection, pain, tissue damage, clip displacement, clip loss, absence of CNSI staining, and excessive CNSI staining, will be recorded and analyzed. The overall complication rate and rates for specific types of complications will be reported. The severity of complications will be assessed using the Clavien-Dindo classification to provide a standardized evaluation of complication severity.
次要结局
- Axillary and distant recurrence rates(Up to 60 months)
- Overall survival (OS), and disease-free survival (DFS)(Up to 60 months)
- Surgical duration(Up to 2 hours)
- Postoperative complications(Up to 60 months)
- The Life Quality Index(Up to 24 months)
- Positive tumor margin rate and re-excision surgery(Up to 6 months)