A Comparative Study to Evaluate Targeting Methods for Axillary Surgery in Patients With Clinically Node-positive Breast Cancer: A Prospective Multicenter Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 330
- 主要终点
- Accuracy of the axillary lymph node targeting method
研究概览
简要总结
The purpose of this study was to compare the use of LuminoMarkTM as a method of targeting axillary lymph nodes with other existing methods used in each institution, such as charcoal staining, needle targeting, and ultrasound-guided skin marking, in patients with breast cancer clinically suspected of metastasis, with or without clipping at the time of diagnosis, regardless of the presence or absence of neoadjuvant chemotherapy. By doing so, the investigators aimed to confirm the safety and usefulness of LuminoMarkTM as a targeting method.
详细描述
In breast cancer patients, lymph node targeting plays an important role in determining the stage and setting the treatment policy, and the existing methods for this purpose include charcoal staining, needle targeting, and ultrasound-guided skin marking. However, these methods have limitations in terms of detection rate and accuracy, and a new targeting method, LuminoMarkTM, shows the potential to replace them. The purpose of this study is to evaluate the detection rate and safety of lymph node targeting using LuminoMarkTM in breast cancer patients and to verify its effectiveness by comparing it with existing targeting methods. The study was designed as a prospective comparative study, and patients diagnosed with breast cancer and requiring lymph node targeting were divided into the LuminoMarkTM group and the existing method group. The existing method group selects a standard method among charcoal staining, needle targeting, and ultrasound-guided skin marking to perform targeting, and the lymph node detection rate, procedure time, complication rate, and patient satisfaction are the main evaluation indicators in both groups. After targeting, the suitability of the detected lymph nodes is confirmed through pathological analysis, and appropriate statistical analysis is performed to compare the difference in detection rates of each method. Through this study, the investigators evaluate whether LuminoMarkTM provides superior detection rates and safety compared to existing lymph node targeting methods, and based on this, the investigators aim to suggest a more effective and reliable targeting method for breast cancer patients.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 to 70 years
- •Women diagnosed with primary invasive breast cancer through biopsy
- •Patients with clinically and imaging-suspected axillary lymph node metastasis, confirmed pathologically (aspiration cytology or needle biopsy)
- •Clinically staged T1-T4, N1-3
- •Patients who have fully understood the clinical trial content (if possible) and signed the informed consent form
排除标准
- •Patients with inadequate radiological evaluation of the axilla before surgery
- •Recurrent breast cancer or inflammatory breast cancer
- •Breast cancer with distant metastasis (Stage 4)
- •Patients with a history of hypersensitivity to the components of the investigational drug
- •Patients scheduled for axillary dissection that does not require targeting of the target lesion
- •Patients with active connective tissue disease (e.g., scleroderma, lupus) that has invaded the skin
- •Patients with locally advanced breast cancer or inflammatory locally advanced breast cancer that is not amenable to surgery
- •Patients with a history of hypersensitivity to the main component or excipients of the investigational drug
- •Female subjects who may become pregnant during the clinical trial period and do not agree to use a highly effective non-hormonal contraception method (e.g., sterilization, intrauterine device, complete abstinence, vasectomy partner) from the time of investigational drug injection until the follow-up visit
- •Pregnant or lactating women
- •Patients who have participated in another clinical trial within 12 weeks before enrollment in this clinical trial
- •Patients deemed unsuitable for participation by the investigator for any other reason
研究组 & 干预措施
LuminoMarkTM group
LuminoMarkTM using group for targeting of axillary lymph node
干预措施: Targeting of axillary lymph nodes using LuminoMark (Procedure)
Conventional group
Conventional method using group for targeting of axillary lymph node
干预措施: Targeting of axillary lymph nodes using conventional method (Procedure)
结局指标
主要结局
Accuracy of the axillary lymph node targeting method
时间窗: From enrollment to the end of observation at 3 weeks
The outcome will be assessed by determining whether the preoperatively marked (targeted) lymph node is successfully identified and retrieved during surgery, and confirmed by postoperative pathological examination. Success (match): The retrieved lymph node is matched with targeted lymph node. Failure (not match): The retrieved lymph node is not matched with targeted lymph node.
Comparison the accuracy rate between LuminoMark group and conventional group
时间窗: At the end of the trial (up to 1 year)
Compare the rate at which the lymph nodes are accurately detected using charcoal staining, needle targeting, ultrasound-guided marking, etc., with the rate at which they are detected using LuminoMark.
次要结局
- Comparion of surgical time between two group(During surgery)
- Comparison of complications between two groups(From enrollment to the end of observation at 3 weeks)
- Adverse drug reactions(From enrollment to the end of observation at 3 weeks)
- Concordance rate between sentinel lymph node and targeted lymph node in both group(From enrollment to the end of observation at 3 weeks)
研究者
JeeYeon Lee
Associate professor
Kyungpook National University Chilgok Hospital