Overview

Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy

Status:
Recruiting
Trial end date:
2023-03-31
Target enrollment:
0
Participant gender:
Female
Summary
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).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fujian Medical University Union Hospital
Criteria
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.