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Use of magnetic tracer for sentinel lymph node biopsy in breast cancer is non inferior to the standard dual tracers technique: A multi-center non-inferior randomized trial
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注册号：

Registration number：

 ChiCTR2000038120 

最近更新日期：

Date of Last Refreshed on：

 2020-09-11 00:47:32 

注册时间：

Date of Registration：

 2020-09-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Use of magnetic tracer for sentinel lymph node biopsy in breast cancer is non inferior to the standard dual tracers technique: A multi-center non-inferior randomized trial

Public title：

Use of magnetic tracer for sentinel lymph node biopsy in breast cancer is non inferior to the standard dual tracers technique: A multi-center non-inferior randomized trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Use of magnetic tracer for sentinel lymph node biopsy in breast cancer is non inferior to the standard dual tracers technique: A multi-center non-inferior randomized trial

Scientific title：

Use of magnetic tracer for sentinel lymph node biopsy in breast cancer is non inferior to the standard dual tracers technique: A multi-center non-inferior randomized trial

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：

Hung Ka Wai Ray 

研究负责人：

Hung Ka Wai Ray 

Applicant：

Hung Ka Wai Ray 

Study leader：

HUNG KA WAI RAY 

申请注册联系人电话：

Applicant telephone：

 +852 91616765

研究负责人电话：

Study leader's
telephone：

+852 91616765

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：

 hkw879@ha.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 hkw879@ha.org.hk

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：

中國香港特別行政區新界上水保健路9號

研究负责人通讯地址：

中國香港特別行政區新界上水保健路9號

Applicant address：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong SAR, China

Study leader's address：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong

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：

北區醫院

Applicant's institution：

North District Hospital

研究负责人所在单位：

北區醫院

Affiliation of the Leader：

North District Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2017.677-T

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethic Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-02-04 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

北區醫院

Primary sponsor：

North District Hospital

研究实施负责（组长）单位地址：

中國香港特別行政區新界上水保健路9號

Primary sponsor's address：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Sponsored by endomagnetic limited

Source(s) of funding：

Sponsored by endomagnetic limited

研究疾病：

乳腺癌  

Target disease：

Breast cancer

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

Compare the identification rate between SPIO and standard dual tracers technique used in sentinel lymph node biopsy in breast cancer patients.  

Objectives of Study：

Compare the identification rate between SPIO and standard dual tracers technique used in sentinel lymph node biopsy in breast cancer patients.

药物成份或治疗方案详述：

This is a multi-center non-inferior randomized trial involving two major breast centers in Hong Kong. The aim of this study is to compare the identification rate between SPIO and standard dual tracers technique (Tc99 + blue dye) used in sentinel lymph node biopsy in breast cancer patients. The primary ends point is the identification rate of sentinel lymph node. The secondary end point will be the time from injection to skin incision, operation times, number of sentinel lymph nodes identified and possible adverse event. According to the a recently published trial on SPIO, the identification rate for the combine technique and magnetic technique were 98.6% and 99.3% respectively(14). With one sided significant level of 0.025, non-inferior margin of 4% and a power of 80%, the calculated sample size in each arm is 150. Patient will be randomized into 2 arms immediate after signing the informed consent by computer generated number in 1 to 1 ratio. Combine technique: Injection of radioisotopes (Tc99) in the radiology department before the procedure. Intraoperative injection of 1 ml methylene blue after GA followed 5 mins message. SLNB will be performed by using the gamma probe. All sentinel lymph nodes identified will be labelled as hot if radioactivity is detected by the gamma probe and “blue” if they show blue in color. The 10s ex vivo count of the SLN will be recorded. Completion of the SLNB is considered as residual 10s count in the axilla < 10% of the highest ex vivo reading and no residual blue node identified. In addition, node that, in the investigator’s judgment, were highly clinically suspicious (i.e. hard or firm) were excised and considered as SLNs. It there is no sentinel lymph node identified, level I & II axillary lymph node dissection will be performed The timing of administration of radioisotope and blue dye, time of the procedure and the number of SLN excised will be recorded. Magnetic technique: Injection of 2 ml of magnetic tracer subcutaneously in the subareolar region at least 20 mins before the operation followed by 5 min massage SLNB will be performed by using SentiMag. All sentinel lymph nodes identified will be labelled as “hot” if magnetic signal is detected by the probe and “brown” if they show brown in color. The ex vivo count of the SLN will be recorded. Completion of the SLNB is considered as residual count in the axilla < 10% of the highest ex vivo reading and no residual brown node identified. In addition, node that, in the investigator’s judgment, were highly clinically suspicious (i.e. hard or firm) were excised and considered as SLNs. If no SLN can be identified by both the SentiMag, level I & II axillary lymph node dissection will be performed The timing of administration of radioisotope and blue dye, time of the procedure and the number of SLN excised will be recorded. Patients will be followed up 3 monthly after operation in the first year. Any adverse event will be related to the use of SPIO will be recorded.  

Description for medicine or protocol of treatment in detail：

This is a multi-center non-inferior randomized trial involving two major breast centers in Hong Kong. The aim of this study is to compare the identification rate between SPIO and standard dual tracers technique (Tc99 + blue dye) used in sentinel lymph node biopsy in breast cancer patients. The primary ends point is the identification rate of sentinel lymph node. The secondary end point will be the time from injection to skin incision, operation times, number of sentinel lymph nodes identified and possible adverse event. According to the a recently published trial on SPIO, the identification rate for the combine technique and magnetic technique were 98.6% and 99.3% respectively(14). With one sided significant level of 0.025, non-inferior margin of 4% and a power of 80%, the calculated sample size in each arm is 150. Patient will be randomized into 2 arms immediate after signing the informed consent by computer generated number in 1 to 1 ratio. Combine technique: Injection of radioisotopes (Tc99) in the radiology department before the procedure. Intraoperative injection of 1 ml methylene blue after GA followed 5 mins message. SLNB will be performed by using the gamma probe. All sentinel lymph nodes identified will be labelled as hot if radioactivity is detected by the gamma probe and “blue” if they show blue in color. The 10s ex vivo count of the SLN will be recorded. Completion of the SLNB is considered as residual 10s count in the axilla < 10% of the highest ex vivo reading and no residual blue node identified. In addition, node that, in the investigator’s judgment, were highly clinically suspicious (i.e. hard or firm) were excised and considered as SLNs. It there is no sentinel lymph node identified, level I & II axillary lymph node dissection will be performed The timing of administration of radioisotope and blue dye, time of the procedure and the number of SLN excised will be recorded. Magnetic technique: Injection of 2 ml of magnetic tracer subcutaneously in the subareolar region at least 20 mins before the operation followed by 5 min massage SLNB will be performed by using SentiMag. All sentinel lymph nodes identified will be labelled as “hot” if magnetic signal is detected by the probe and “brown” if they show brown in color. The ex vivo count of the SLN will be recorded. Completion of the SLNB is considered as residual count in the axilla < 10% of the highest ex vivo reading and no residual brown node identified. In addition, node that, in the investigator’s judgment, were highly clinically suspicious (i.e. hard or firm) were excised and considered as SLNs. If no SLN can be identified by both the SentiMag, level I & II axillary lymph node dissection will be performed The timing of administration of radioisotope and blue dye, time of the procedure and the number of SLN excised will be recorded. Patients will be followed up 3 monthly after operation in the first year. Any adverse event will be related to the use of SPIO will be recorded.  

纳入标准：

Inclusion criteria

排除标准：

Patient treated with neoadjuvant chemotherapy, history of axillary radiation, history of ipsilateral axillary surgery; non palpable breast cancer requiring simultaneous localization; patient with known intolerance or hypersensitivity to iron or dextran compounds, magnetic tracers or SPIO; with an iron-overload disease; with pacemakers or other implantable devices on the chest wall; with known hypersensitivity to blue dye; who could not or did not receive radioisotope

Exclusion criteria：

Patient treated with neoadjuvant chemotherapy, history of axillary radiation, history of ipsilateral axillary surgery; non palpable breast cancer requiring simultaneous localization; patient with known intolerance or hypersensitivity to iron or dextran compounds, magnetic tracers or SPIO; with an iron-overload disease; with pacemakers or other implantable devices on the chest wall; with known hypersensitivity to blue dye; who could not or did not receive radioisotope

研究实施时间：

Study execute time：

从 From 2020-11-02 00:00:00至 To 2023-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-11-02 00:00:00 至 To 2022-10-31 00:00:00

干预措施：

Interventions：

组别：

A

样本量：

 150

Group：

A

Sample size：

干预措施：

Magnetic tracer

干预措施代码：

Intervention：

Magnetic tracer

Intervention code：

组别：

B

样本量：

 150

Group：

B

Sample size：

干预措施：

Dual tracer

干预措施代码：

Intervention：

Dual tracer

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 北區醫院 

单位级别：

 三级医院 

Institution
hospital：

North District Hospital

Level of the institution：

Tertiary

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 威爾士親王醫院 

单位级别：

 三级医院 

Institution
hospital：

Princess Margaret Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Identification rate of SLN

指标类型：

主要指标

Outcome：

Identification rate of SLN

Type：

Primary 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：

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 岁 years
最大 Max age 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

A online computer generated randomization will be performed by the recruiters immediately after recruitment of the participants

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

A online computer generated randomization will be performed by the recruiters immediately after recruitment of the participants

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：

N/A

Blinding：

NA

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

是Yes

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）：

The IPD will be uploaded

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

The IPD will be uploaded

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：

A standardized case reporting form will be used to record the study outcome The result will be recorded in a standardized database

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

A standardized case reporting form will be used to record the study outcome The result will be recorded in a standardized database

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-09-11 00:47:32
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