Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-28 @ 11:14 AM
Study NCT ID:
NCT05512468
Status:
UNKNOWN
Last Update Posted:
2022-08-23
First Post:
2022-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy
Sponsor:
Fujian Medical University Union Hospital
Organization:
Study Overview
Official Title:
Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
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.
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?: