Contrast Enhanced Ultrasonography-guided Sentinel Lymph Node Biopsy after Introducing Twirl Breast Marker for Axillary Lymph Node-positive Breast Cancer

JRCT ID: jRCTs051210034

Registered date:04/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 04/06/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Hookwire-guided sentinel lymph node biopsy using contrast-enhanced ultrasonography after introducing Twirl breast markers

Outcome(s)

• Primary Outcome: Ratio of patients who have spared axillary lymph node dissection

Secondary Outcome

Proportion of Twirl-LNs to sentinel lymph nodes
Tumor burden in Twirl-LN
Number of metastatic lymph nodes among non-sentinel lymph nodes
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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: Miyake Tomohiro
• Source(s) of Monetary Support: Japan Society for the Promotion of Science