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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04744506
Other study ID # 2020-535
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2020
Est. completion date July 15, 2025

Study information

Verified date December 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a multi-center, prospective, self-controlled study, to evaluate the feasibility of targeted axillary lymph node resection (TAD) guided by tissue marker clip with methylene blue single tracer after neoadjuvant chemotherapy in T1-4N1M0 breast cancer patients. Evaluate the accuracy and false negative rate of TAD, comparing with sentinel lymph node biopsy, and explore a new axillary-preserving mode after neoadjuvant chemotherapy for breast cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 332
Est. completion date July 15, 2025
Est. primary completion date July 15, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. breast cancer with axillary lymph node metastasis confirmed by puncture pathology (T1-3N1M0) 2. accord with the indications of neoadjuvant chemotherapy for breast cancer 3. informed consent has been signed 4. Preoperative anesthesia assessment is low to medium risk (ASA score) Exclusion Criteria: 1. There are absolute and relative contraindications of chemotherapy 2. Refuse surgery or can't tolerate surgery 3. Unable to cooperate or unwilling to place Marker 4. Pregnant women 5. Do not have full capacity for behavior, such as mental patients, drug dependence, anxiety and so on 6. Diabetes patients who are difficult to control 7. Excessive smokers 8. high risk of anesthesia 9. Any serious complications are not suitable for patients participating in this study

Study Design


Intervention

Device:
Tissue Marker Clip
Tissue Marker Clip Placed in Metastatic Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)

Locations

Country Name City State
China 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary False negative rate (FNR) of targeted axillary lymph node resection False negative rate (FNR) of targeted axillary lymph node resection of breast cancer with methylene blue single tracer after neoadjuvant chemotherapy for T1-3N1M0 breast cancer Up to 60 months
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