Contrast Enhanced Ultrasonography-guided Sentinel Lymph Node Biopsy after Introducing Twirl Breast Marker for Axillary Lymph Node-positive Breast Cancer
- Conditions
- Breast cancerD001943
- Registration Number
- JPRN-jRCTs051210034
- Lead Sponsor
- Miyake Tomohiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 20
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ratio of patients who have spared axillary lymph node dissection
- Secondary Outcome Measures
Name Time Method Proportion of Twirl-LNs to sentinel lymph nodes<br>Tumor burden in Twirl-LN<br>Number of metastatic lymph nodes among non-sentinel lymph nodes<br>Ratio of Twirl-LN which could be sampled by means of intraoperative ultrasonography and conventional sentinel lymph node biopsy method, i.e., dye or radio-isotope method