Breast Cancer Clinical Trial
Official title:
Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy
The primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. The secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing ALND after NACT).
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Female; 2. Aged >=18 years; 3. With invasive breast cancer; 4. Patients to be treated with neoadjuvant chemotherapy; 5. Patients scheduled to undergo routine fine needle aspiration (FNA) or core biopsy of abnormal axillary lymph node; 6. Patients with operable breast cancer; 7. Heart, lung, liver and kidney function well, suitable for patients undergoing surgery; 8. Informed consent patients. Exclusion Criteria: - 1. Patients who do not plan or are unable to operate; 2. Patients with distant metastasis were excluded; 3. Patients without invasive cancer components in DCIS alone; 4. Patients who are unable to cooperate with the doctor's recommended surgical treatment (breast conserving surgery or radical surgery) due to personal or family factors; 5. Patients with serious cardiopulmonary diseases, uncontrolled infectious diseases and other non tumor related diseases who can not tolerate comprehensive treatment such as surgery and chemotherapy; 6. Patients with mental illness or other reasons unable to sign informed consent; 7. Patients with poor medical compliance who cannot complete the trial treatment process and follow-up according to the standard according to the researcher's opinion. |
Country | Name | City | State |
---|---|---|---|
China | Study Officials | Fuzhou | Fujian |
Lead Sponsor | Collaborator |
---|---|
Fujian Medical University Union Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification rate of tattooed node | Proportion of patients in whom tattooed node/s were identified. | 12 months | |
Secondary | Concordance of tattooed node and sentinel node | Concordance rate: defined as the percent of patients in whomthe tattooed nodeis the sentinel node. | 12 months | |
Secondary | Migration of black dye into other nodes | The number of black nodes at the time of sentinel node biopsy or axillary lymph node dissection. | 12 months |
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