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Trial Title:
Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy
NCT ID:
NCT05512468
Condition:
Breast Cancer
Neoadjuvant Therapy
Sentinel Lymph Node Biopsy
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
carbon dye
Description:
Tattooing (marking) of biopsied node with carbon dye at the time or at a separate session
of fine needle aspiration or core biopsy or separate visit under ultrasound guidance. The
dye will be injected in the cortex of the node and the perinodal tissue under ultrasound
guidance. Patients will undergo standard (routine) armpit surgery and may receive
neoadjuvant chemotherapy as planned by the clinical team. This could be removal of a few
lymph glands (sentinel node biopsy) or removal of all the lymph glands (axillary lymph
node dissection) in the armpit. The surgeon will try to identify and remove the tattooed
lymph gland at the time of planned armpit surgery.
Arm group label:
Experimental: Tattooing of biopsied node
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).
Detailed description:
Pretreatment evaluation of axillary lymph nodes and marking of biopsied nodes in patients
with newly diagnosed breast cancer is becoming routine practice. Tagging of biopsied
axillary lymph nodes with metal markers, similar to what is done for suspicious breast
lesions, is being adopted in clinical practice. The need to mark a positive axillary
lymph node becomes especially relevant in cases where neoadjuvant chemotherapy (NACT) is
anticipated so that these nodes may be identified at the time of surgery. Measures that
improve both the accuracy of nodal evaluation after NACT and the ability to assess
treatment response are desirable in order to tailor therapies for breast cancer
treatment. The investigators sought to test tattooing of biopsied axillary lymph nodes
with a sterile black carbon suspension.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Study Officials
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Chuan Wang
Phone:
13365910252
Email:
chuanwang1968@outlook.com
Contact backup:
Last name:
Minyan Chen
Phone:
15980278832
Email:
15980278832@163.com
Start date:
March 1, 2020
Completion date:
March 31, 2023
Lead sponsor:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Source:
Fujian Medical University Union Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512468
