Study Overview: Targeted Axillary Dissection with Carbon Marking for Breast Cancer
Background
Neoadjuvant chemotherapy (NAC) can help breast cancer patients with lymph node metastases achieve complete responses, possibly eliminating the need for extensive lymph node removal. Traditional methods for targeted axillary dissection (TAD) using tissue markers have issues like marker loss and high costs. A new method using carbon nanoparticle suspension injection (CNSI) could provide a more reliable solution, enhancing the TAD process. This study focuses on assessing various TAD techniques using CNSIs and their practical value in treating locally advanced breast cancer.
Methods
This study will include 126 patients diagnosed with breast cancer and suspicious lymph nodes who respond well to NAC. Participants will be divided into three groups to receive different TAD methods: 1. Conventional tissue clips (CG-TAD); 2. CNSI lymph node marking (CN-LNM); 3. Peritumoral CNSI mapping (PCN-MAP). Key measurements will include the success of retrieving marked lymph nodes, the number and agreement of sentinel and marked lymph nodes, and any complications that arise. Secondary measurements will look at recurrence rates, survival rates, surgical time, complications post-surgery, quality of life, and the status of tumor margins. We will follow strict statistical guidelines to ensure valid results.
Discussion
This study is designed to assess how effective and precise CNSI can be for targeted axillary dissection in breast cancer patients post-NAC. We aim to show how it can reduce surgery-related complications and costs while improving accuracy.
Trial Registration
Registered at Clinicaltrials.gov, NCT04744506 on December 27, 2020, with updates on September 24, 2024. Protocol Version Ver 1.2, dated September 17, 2024.
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