NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051210034

Registered date:04/06/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment04/06/2021
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Hookwire-guided sentinel lymph node biopsy using contrast-enhanced ultrasonography after introducing Twirl breast markers

Outcome(s)

Primary OutcomeRatio of patients who have spared axillary lymph node dissection
Secondary OutcomeProportion 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
GenderFemale
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

Contact

Public contact
Name Tomohiro Miyake
Address 2-15 Yamada-oka, Suita city, Osaka, 565-0871, Japan Osaka Japan 565-0871
Telephone +81-6-6879-3772
E-mail t_miyake@onsurg.med.osaka-u.ac.jp
Affiliation Osaka University Hospital
Scientific contact
Name Tomohiro Miyake
Address 2-15 Yamada-oka, Suita city, Osaka, 565-0871, Japan Osaka Japan 565-0871
Telephone +81-6-6879-3772
E-mail t_miyake@onsurg.med.osaka-u.ac.jp
Affiliation Osaka University Hospital