Tissue Marker Clip: Tissue Marker Clip to be Placed in Metastatic Axillary Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)
Carbon Nanoparticle Suspension Injection: Carbon Nanoparticle Suspension Injection to be Placed in Metastatic Axillary Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)
Carbon Nanoparticle Suspension Injection: Carbon Nanoparticle Suspension Injection to be Placed around Primary Tumor (Before Neoadjuvant Chemotherapy for Breast Cancer)
Study summary
This study evaluates the efficacy and feasibility of Carbon Nanoparticle Suspension Injection (CNSI) for Targeted Axillary Dissection (TAD) in breast cancer patients undergoing neoadjuvant chemotherapy (NAC), compared to traditional clip-based methods. By leveraging CNSI's enhanced visibility and stability, the study aims to improve the precision of lymph node removal, reduce surgical complications, and potentially transform clinical practices. Conducted across multiple centers, this randomized controlled trial focuses on clinical outcomes such as lymph node retrieval rates and the accuracy of surgical staging, aiming to establish a safer, more effective approach to managing axillary lymph nodes in breast cancer surgery.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Female patients aged 18 to 85 years are eligible.
2. Participants must have a histologically confirmed diagnosis of breast cancer, classified as cT1-4N1-2aM0 according to the 8th edition of the AJCC (American Joint Committee on Cancer) TNM classification system.
3. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
4. Clinical re-staging must indicate an axillary node status of ycN0 following NAC.
5. Participants must provide written informed consent to partake in the trial, acknowledging understanding and agreement to the procedures and risks involved.
Exclusion Criteria:
1. Patients with metastatic breast cancer (Stage IV).
2. Diagnosed with inflammatory breast cancer or bilateral breast cancer.
3. History of axillary surgical procedures.
4. Any medical, psychological, or social conditions that would prevent adherence to the study protocol or completion of the treatment or follow-up.
5. Known allergy to carbon nanoparticles or presence of severe comorbid conditions or other serious underlying medical issues.
6. Current or prior participation in another clinical trial that could interfere with the outcome of this study or affect the safety and well-being of the participants.
Primary outcome measure(s)
Lymph node retrieval rate marked — Up to 2 months The proportion of successfully retrieved marked lymph nodes will be calculated and compared among the study groups to evaluate the effectiveness of each marking technique.
Number of sentinel and marked lymph nodes — Up to 2 months The mean, median, and range of the number of sentinel and marked lymph nodes harvested during surgery will be recorded and compared to assess the efficacy of the marking techniques in identifying lymph nodes of interest.
Concordance between marked and sentinel lymph nodes — Up to 2 months The consistency between marked lymph nodes and intraoperatively identified sentinel lymph nodes will be evaluated by calculating the percentage of marked nodes that are also sentinel nodes and vice versa.
Complication rate — Up to 60 months All surgery-related complications, including but not limited to hemorrhage, lymphedema, infection, pain, tissue damage, clip displacement, clip loss, absence of CNSI staining, and excessive CNSI staining, will be recorded and analyzed. The overall complication rate and rates for specific types of complications will be reported. The severity of complications will be assessed using the Clavien-Dindo classification to provide a standardized evaluation of complication severity.
Trial sites (1)
Facility
City
Region
Status
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou
Zhejiang
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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