jRCTs051210034RecruitingNot Applicable
Clinical Trial for the Evaluation of Efficacy and Safety of Contrast Enhanced Ultrasonography-guided Sentinel Lymph Node Biopsy after Introducing Twirl Breast Marker for Axillary Lymph Node-positive Breast Cancer
Not provided0 sites20 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to 90age old not (—)
- Sex
- Female
Inclusion Criteria
- •(1) Patients with the ability to consent who are 20 years old or older and younger than 90 years old at the time of obtaining informed consent
- •(2) Clinically T1-2N1M0 breast cancer patients with 1 to 2 positive axillary lymph nodes of whicn at least one axillary lymph node has been confirmed to harbor metastasis by fine needle aspiration cytology
- •(3) Patients whose condition are expected to be stable for longer than 6 months at the time of obtaining the informed consent
- •(4) Patients for whom a written consent has been obtained for participation in this study
Exclusion Criteria
- •(1) Patients with palpable hard nodes
- •(2) Patients with radiologically proven matted nodes or gross extranodal disease
- •(3) Patients who have been treated with preoperative chemotherapy or hormonal therapy for breast cancer
- •(4) Patients who are during or possibilities of pregnancy
- •(5) Patients who are allergic to metal or egg
- •(6) Patients with coronary artery disease
- •(7) Patients who seem not eligible for the present study
Outcomes
Primary Outcomes
-
Ratio of patients who have spared axillary lymph node dissection
Secondary Outcomes
No secondary outcomes reported
Investigators
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