Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04482803
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2020-07-04
Brief Title:
Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node for CN Breast Cancer
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Feasibility Study of Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node After Neoadjuvant Systemic Therapy for Clinically Assessed Positive Axillary Lymph Node cN Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-10
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:
To explore the feasibility of target biopsy of carbon nanoparticles labelled lymph node after neoadjuvant systemic therapy for cN breast cancer and evaluate whether it can accurately predict axillary lymph node status after neoadjuvant systemic therapy
Detailed Description:
Locally advanced breast cancer patients with clinical assessed positive axillary lymph node cN who receive neoadjuvant systemic therapy NST will be enrolled in this study Before NST one of the suspected lymph nodes will be subjected to ultrasound-guided core needle biopsy CNB or fine needle aspiration FNA and a locating clip will be placed Meanwhile a small amount of Kanarine Carbon Nanoparticles Suspension Injection will be injected into or around the cortex of the locating lymph node as well as other positive lymph nodes All patients will be confirmed to have axillary lymph node metastasis by pathologic or cytologic examination After NST FNA will be performed again for the lymph nodes labelled with previous locating clip During the operation the clip labelled lymph nodes were identified with carbon and sent to pathology separately Meanwhile the remaining carbon labelled lymph nodes were also separately examined Axillary lymph node dissection will be performed in all patients The detection rate of labelled lymph node will be record and the pathological results of re-FNA of labelled lymph nodes will be compared with postoperative pathological results Meanwhile we will also analysis whether carbon labelled lymph node biopsy could predict the overall status of axillary lymph nodes after NST
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