ChiCTR2600124842 版本V1.0 版本创建时间2026/05/18 15:51:42 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600124842 

最近更新日期：

Date of Last Refreshed on：

2026-05-18 15:51:31 

注册时间：

Date of Registration：

2026-05-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

纳米炭标记阳性淋巴结联合亚甲蓝示踪对比标准双示踪用于乳腺癌患者的腋窝降期手术--一项前瞻性随机对照研究

Public title：

Nanocarbon-labeled positive lymph nodes combined with methylene blue tracing for comparison with standard dual-tracing in axillary de-escalation surgery for breast cancer patients - A prospective randomized controlled study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

纳米炭标记阳性淋巴结联合亚甲蓝示踪对比标准双示踪用于乳腺癌患者的腋窝降期手术--一项前瞻性随机对照研究

Scientific title：

Nanocarbon-labeled positive lymph nodes combined with methylene blue tracing for comparison with standard dual-tracing in axillary de-escalation surgery for breast cancer patients - A prospective randomized controlled study

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

李诗恒 

研究负责人：

石爱平;吴迪 

Applicant：

Li Shiheng 

Study leader：

Shi Aiping;Wu Di 

申请注册联系人电话：

Applicant telephone：

+86 136 1078 1437

研究负责人电话：

Study leader's telephone：

+86 158 0430 1451

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

lishiheng@jlu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

13364308696@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

吉林省长春市朝阳区新民大街1号

研究负责人通讯地址：

吉林省长春市朝阳区新民大街1号

Applicant address：

No.1 Street, Chaoyang District, Changchun, Jilin

Study leader's address：

No.1 Street, Chaoyang District, Changchun, Jilin

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

吉林大学第一医院

Applicant's institution：

The First Hospital of Jilin University

研究负责人所在单位：

吉林大学第一医院

Affiliation of the Leader：

The First Hospital of Jilin University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025-HS-098

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

吉林大学临床研究管理委员会

Name of the ethic committee：

Jilin University Clinical Research Management Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025-09-16 00:00:00

伦理委员会联系人：

郭迪

Contact Name of the ethic committee：

Guo Di

伦理委员会联系地址：

吉林省长春市朝阳区新民大街1号

Contact Address of the ethic committee：

No.1 Street, Chaoyang District, Changchun, Jilin

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 187 4404 7115

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

吉林大学第一医院

Primary sponsor：

The First Hospital of Jilin University

研究实施负责（组长）单位地址：

吉林省长春市朝阳区新民大街1号

Primary sponsor's address：

No.1 Street, Chaoyang District, Changchun, Jilin

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

吉林

市(区县)：

长春

Country：

China

Province：

Jilin

City：

Changchun

单位(医院)：

吉林大学第一医院

具体地址：

吉林省长春市朝阳区新民大街1号

Institution
hospital：

The First Hospital of Jilin University

Address：

No.1 Street, Chaoyang District, Changchun, Jilin

经费或物资来源：

吉林大学第一医院

Source(s) of funding：

The First Hospital of Jilin University

Target disease：

Breast Cancer

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要研究目的： 1. 对新辅助治疗后纳米炭标记进行靶向淋巴结摘除联合亚甲蓝单示踪前哨淋巴结的假阴性率和核素、亚甲蓝双示踪的假阴性进行比较。 次要研究目的： 1.比较纳米炭标记阳性淋巴结联合亚甲蓝单示踪与传统双示踪（核素和亚甲蓝）标记淋巴结在检出率方面的差异。 2.分析影响纳米炭检出率和假阴性率的潜在因素（如原发肿瘤特征、新辅助化疗方案、新辅助化疗反应等）。 3.评估该技术的安全性（腋窝的复发率、不良反应发生率）。 4.探索纳米炭标记在指导个体化腋窝手术决策（如避免ALND）中的潜在价值。  

Objectives of Study：

Main research objective: 1.Compare the false negative rates of targeted lymph node dissection combined with methylene blue single tracer for sentinel lymph nodes after neoadjuvant therapy, as well as the false negative rates of radionuclide and methylene blue dual tracer. Secondary research objectives: 1. Compare the differences in detection rates between the positive lymph nodes labeled with nanocarbon combined with methylene blue single tracer and the traditional dual tracer (radionuclide and methylene blue) labeling of lymph nodes; 2.Analyze potential factors affecting the detection rate and false negative rate of nanocarbon (such as primary tumor characteristics, neoadjuvant chemotherapy regimen, neoadjuvant chemotherapy response, etc.); 3. Evaluate the safety of this technique (recurrence rate in the axilla, incidence of adverse reactions); 4.Explore the potential value of nanocarbon labeling in guiding individualized axillary surgery decisions (such as avoiding ALND).

药物成份或治疗方案详述：

A 组：标准治疗组：手术时采用核素和亚甲蓝双示踪前哨淋巴结的受试者 B 组：实验组：新辅助治疗前采用纳米炭定位阳性淋巴结，手术时摘除定位的阳性淋巴结，并用亚甲蓝示踪前哨淋巴结的受试者  

Description for medicine or protocol of treatment in detail：

Group A: Standard treatment group: Subjects who underwent surgery with dual tracer (nucleotide and methylene blue) for marking the sentinel lymph nodes. Group B: Experimental group: Subjects who underwent pre-treatment with new adjuvant therapy, then had positive lymph nodes located using nano-carbon, had the located positive lymph nodes removed during surgery, and had the sentinel lymph nodes marked with methylene blue. 

纳入标准：

1.年龄 ≥ 18 岁，女性; 2.组织学确诊为浸润性乳腺癌（任何亚型）; 3.临床分期：cT1-3, N1-2, M0（新辅助治疗前）; 4.接受标准新辅助化疗及内分泌治疗（NAT）方案，疗程完整（医生判断达到治疗目的）; 5.NAT后计划行乳腺癌手术（保乳或全乳切除）及腋窝前哨淋巴结活检术（SLNB)或清扫术（ALND）; 6.签署知情同意书。

Inclusion criteria

1.Age >= 18 years old, female; 2. Histologically diagnosed with invasive breast cancer (any subtype); 3.Clinical stage: cT1-3, N1-2, M0 (before neoadjuvant therapy); 4. Received standard neoadjuvant chemotherapy and endocrine therapy (NAT) regimen, with complete treatment course (as determined by the doctor to achieve the therapeutic goal); 5. After NAT, plans to undergo breast cancer surgery (lumpectomy or total mastectomy) and axillary sentinel lymph node biopsy (SLNB) or dissection (ALND); 6. Signed informed consent form.

排除标准：

1. 对纳米炭、碘剂或研究涉及的任何染料过敏史; 2. 既往同侧腋窝手术史（如淋巴结活检、手术); 3.合并其他器官恶性肿瘤; 4. 炎性乳腺癌; 5. 妊娠或哺乳期妇女; 6. 严重心、肝、肾功能不全，无法耐受手术; 7. 无法配合研究随访。

Exclusion criteria：

1.History of allergy to nano-carbon, iodine agents or any dyes involved in the study; 2.Previous history of surgery on the same side axilla (such as lymph node biopsy, surgery); 3.Concurrent malignant tumors in other organs; 4. Inflammatory breast cancer; 5.Pregnant or lactating women; 6.Severe dysfunction of heart, liver or kidney, unable to tolerate surgery; 7.Unable to cooperate with the study follow-up.

研究实施时间：

Study execute time：

从 From 2025-10-01 00:00:00至 To 2027-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-05-18 00:00:00 至 To 2027-10-01 00:00:00  

干预措施：

Interventions：

组别：

标准治疗组

样本量：

187

Group：

Standard treatment group

Sample size：

干预措施：

双示踪前哨淋巴结活检（锝99、亚甲蓝）

干预措施代码：

Intervention：

Double tracer sentinel lymph node biopsy (technetium 99, methylene blue)

Intervention code：

组别：

试验组

样本量：

187

Group：

Experimental group

Sample size：

干预措施：

纳米炭标记的靶向淋巴结摘除和亚甲蓝示踪前哨淋巴结活检

干预措施代码：

Intervention：

Nanocarbon-labeled targeted lymph node excision and methylene blue tracing of sentinel lymph node biopsy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 吉林 

市(区县)：

 长春 

Country：

China 

Province：

Jilin 

City：

Changchun 

单位(医院)：

吉林大学第一医院 

单位级别：

三甲 

Institution
hospital：

The First Hospital of Jilin University

Level of the institution：

Tertiay A

测量指标：

Outcomes：

指标中文名：

纳米炭标记淋巴结联合亚甲蓝示踪前哨淋巴结的假阴性率

指标类型：

主要指标

Outcome：

The false negative rate of lymph node labeling with nano-carbon combined with methylene blue for tracing sentinel lymph nodes

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

标准双示踪前哨淋巴结活检的假阴性率

指标类型：

主要指标

Outcome：

The false negative rate of standard double-tracer sentinel lymph node biopsy

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

新辅助化疗后腋窝纳米炭标记淋巴结联合亚甲蓝示踪前哨淋巴结检出率

指标类型：

次要指标

Outcome：

The detection rate of sentinel lymph nodes by axillary nano-carbon labeled lymph nodes combined with methylene blue tracing after neoadjuvant chemotherapy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

传统双示踪（核素和亚甲蓝）作为标准对照的检出率

指标类型：

次要指标

Outcome：

The detection rate of traditional dual tracer (radioisotope and methylene blue) as the standard control

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

纳米炭靶向淋巴结活检联合蓝染料单示踪 vs. 传统双示踪在检出阳性淋巴结方面的差异（检出率、灵敏度等）

指标类型：

次要指标

Outcome：

The difference in the detection of positive lymph nodes between targeted lymph node biopsy using nano-carbon and single tracer with blue dye versus traditional double tracer (in terms of detection rate, sensitivity, etc.)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良反应发生率（按类型和严重程度）

指标类型：

次要指标

Outcome：

Incidence of adverse reactions (by type and severity)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

腋窝淋巴结

组织：

Sample Name：

lymph node

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

采用简单随机化方法进行分组。随机序列的产生方式如下：借助SPSS27.0软件的随机数生成功能，为所有符合纳入标准的受试者生成1-100的随机数字，随机数字≤50分配至 A 方法组，随机数字 > 50分配至 B 方法组，若最终两组样本量不等（如 A 组 231 例、B 组 229 例），则对最接近 50 的差值病例进行调整（如将 A 组中随机数字最接近 50 的 1 例调整至 B 组），确保两组样本量均衡。随机序列由未参与临床试验执行过程的统计人员独立生成并妥善保存，以保证随机序列的随机性和保密性，避免人为因素对分组结果造成干扰。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The participants were grouped using a simple randomization method. The generation of the random sequence was as follows: Using the random number generation function of SPSS 27.0 software, random numbers ranging from 1 to 100 were generated for all eligible participants. Random numbers <= 50 were assigned to the A method group, and random numbers > 50 were assigned to the B method group. If the sample sizes of the two groups were unequal (for example, 231 cases in group A and 229 cases in group B), the cases with the closest difference to 50 were adjusted (for example, 1 case with the randomly generated number closest to 50 in group A was adjusted to group B) to ensure the balance of sample sizes between the two groups. The random sequence was independently generated and properly stored by a statistician who was not involved in the execution of the clinical trial to ensure the randomness and confidentiality of the sequence, and to avoid the interference of human factors on the grouping results.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

鉴于本试验中不同示踪剂注射时间存在差异，且医护操作者需通过特定手段检测示踪剂，医护操作者无法设盲。本试验对受试者及数据分析者实施盲法： 对受试者：通过统一的试验说明告知其分组信息处于保密状态，避免其主动探寻分组相关线索；在试验过程中，避免向受试者透露任何可能暗示分组的信息（如示踪剂特性、检测流程差异等）。 对数据分析者：在数据录入、核查及统计分析阶段，所有数据均去除可识别分组的标识，仅以代码形式呈现，确保数据分析者无法通过数据特征推断分组情况。 培训管理：针对参与试验的所有人员（尤其是知晓分组信息的医护操作者）开展专项培训，明确其需严格遵守盲法规定，不得向受试者、数据分析者及其他无关人员透露分组信息，避免因信息泄露破坏盲态。

Blinding：

Given that the injection times of different tracers in this trial were different, and the medical staff needed to detect the tracers through specific means, the medical staff could not be blinded. Therefore, in this trial, a blind method was implemented for the subjects and the data analysts: For the subjects: Through a unified trial explanation, inform them that the group information is kept confidential and to avoid them actively seeking clues related to the groups; during the trial, do not disclose to the subjects any information that might imply the groups (such as the characteristics of the tracers, differences in the detection process, etc.). For the data analysts: During the data entry, verification, and statistical analysis stages, all data should have the identifiers that can identify the groups removed, and be presented only in code form to ensure that the data analysts cannot infer the group situation through the data characteristics. Training management: Conduct special training for all participants in the trial (especially the medical staff who know the group information), clearly stating that they must strictly abide by the blind method regulations and must not disclose the group information to the subjects, data analysts, or other irrelevant personnel to avoid damaging the blind state due to information leakage.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

数据管理 描述录入、编码、保密及储存的方案，包括任何用来提高数据质量的相关措施（如双重录入、数据的范围检查等） 数据录入由指定的SUB-I和临床录入员录入，根据入组顺序进行编码。包含标本信息和检验结果的数据库仅可被获得授权的研究者以及指定的试验管理研究任何和/或协作者访问。数据库的用户认证高度安全，并通过使用基于国际标准的网络安全策略和规范实现，以便防止未经授权的访问。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data management: Describe the plan for data entry, coding, confidentiality and storage, including any measures to improve data quality (such as double entry, range check of data, etc.) Data entry is conducted by the designated SUB-I and clinical data entry clerks, encoded according to the order of enrollment. The database containing specimen information and test results is accessible only to authorized researchers, designated trial management researchers, and any or all collaborators. User authentication for the database is highly secure and achieved through the use of international standard security policies and norms to prevent unauthorized access.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-05-18 15:51:31