Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04744506
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-02-09
First Post:
2020-12-27
Brief Title:
Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Targeted Axillary Dissection Using Carbon Marking for Patients With Node-positive Breast Cancer Following Neoadjuvant Therapy TADCOM a Prospective Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CNSIs 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
Detailed Description:
Objective This study aims to assess the clinical feasibility accuracy and effectiveness of CNSI in targeted axillary dissection compared to traditional tissue marker clips in patients with breast cancer undergoing neoadjuvant chemotherapy NAC
Background Breast cancer remains one of the most prevalent cancers among women globally Neoadjuvant chemotherapy NAC has significantly advanced the management of locally advanced breast cancer enabling more conservative surgical approaches and reducing the dependency on axillary lymph node dissection ALND which is often associated with long-term complications such as lymphedema and chronic pain Traditional TAD methods using tissue marker clips have challenges including high costs and potential for marker loss CNSI presents a novel approach with potential for enhanced surgical precision and reduced complication rates
Methods The study employs a multicenter randomized controlled trial design to compare the outcomes of TAD using CNSI versus conventional clip-based methods Patients with clinically node-positive breast cancer who achieve clinical node-negative status post-NAC are enrolled The primary endpoints include the rate of successful lymph node retrieval the incidence of surgical complications and the accuracy of lymph node staging
Innovation CNSI is designed to improve the visibility and stability of lymph nodes during surgery potentially increasing the precision of cancerous node removal and minimizing the need for subsequent surgical interventions Its unique properties such as the slow metabolic rate and strong pigmentation ensure prolonged visibility and facilitate easier identification during surgery
Significance By enhancing the effectiveness of TAD CNSI could transform clinical practices in breast cancer surgery reducing the physical burden of surgery and improving the quality of life for patients The studys findings could lead to broader adoption of CNSI in surgical oncology setting a new standard for axillary management in breast cancer
Conclusion This research could significantly impact breast cancer treatment protocols by providing a safer more cost-effective and clinically advantageous method for axillary lymph node management potentially leading to widespread changes in surgical approaches and patient outcomes
Background Breast cancer remains one of the most prevalent cancers among women globally Neoadjuvant chemotherapy NAC has significantly advanced the management of locally advanced breast cancer enabling more conservative surgical approaches and reducing the dependency on axillary lymph node dissection ALND which is often associated with long-term complications such as lymphedema and chronic pain Traditional TAD methods using tissue marker clips have challenges including high costs and potential for marker loss CNSI presents a novel approach with potential for enhanced surgical precision and reduced complication rates
Methods The study employs a multicenter randomized controlled trial design to compare the outcomes of TAD using CNSI versus conventional clip-based methods Patients with clinically node-positive breast cancer who achieve clinical node-negative status post-NAC are enrolled The primary endpoints include the rate of successful lymph node retrieval the incidence of surgical complications and the accuracy of lymph node staging
Innovation CNSI is designed to improve the visibility and stability of lymph nodes during surgery potentially increasing the precision of cancerous node removal and minimizing the need for subsequent surgical interventions Its unique properties such as the slow metabolic rate and strong pigmentation ensure prolonged visibility and facilitate easier identification during surgery
Significance By enhancing the effectiveness of TAD CNSI could transform clinical practices in breast cancer surgery reducing the physical burden of surgery and improving the quality of life for patients The studys findings could lead to broader adoption of CNSI in surgical oncology setting a new standard for axillary management in breast cancer
Conclusion This research could significantly impact breast cancer treatment protocols by providing a safer more cost-effective and clinically advantageous method for axillary lymph node management potentially leading to widespread changes in surgical approaches and patient outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None