Viewing Study NCT03355261


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Study NCT ID: NCT03355261
Status: COMPLETED
Last Update Posted: 2020-02-20
First Post: 2017-11-14
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)
Sponsor: Shengjing Hospital
Organization:

Study Overview

Official Title: Long-term Tracing for Axillary Lymph Nodes Dissection in the Patients With Fusion Lymph Node Before Neo-adjuvant Chemotherapy
Status: COMPLETED
Status Verified Date: 2020-02
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 investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer.
Detailed Description: Guided by ultrasound, 0.3 mL of CNs suspension was injected in a fusion node prior to NAC in 110 patients with local advanced breast cancer. Patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of NAC. The distribution by intercostobrachial nerves (ICBN) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to NAC.

Study Oversight

Has Oversight DMC: True
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?: