Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node for CN+ Breast Cancer
NCT04482803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159
Last updated 2024-10-15
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.
Conditions
- Location and Biopsy of Axillary Lymph Nodes
Interventions
- DRUG
-
Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes
Before NST, one of the clinically assesed positive lymph nodes will be subjected to ultrasound-guided CNB or FNA, and a locating clip (Ultraclip, BARD) will be placed. Meanwhile, a small amount of Kanarine (carbon nanoparticles suspension injection, 0.5ml:25mg, H20073246) will be injected into or around the cortex of the locating lymph node and other clinically assessed positive lymph nodes. Preoperative FNA will be performed again for locating clip labelled node.
Sponsors & Collaborators
-
The First Affiliated Hospital with Nanjing Medical University
lead OTHER
Principal Investigators
-
Xiaoming Zha, Doctor · The First Affiliated Hospital with Nanjing Medical University
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-24
- Primary Completion
- 2022-12-02
- Completion
- 2023-05-24
Countries
- China
Study Locations
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