Breast cancer Breast cancer
Conditions
Interventions
Hookwire-guided sentinel lymph node biopsy using contrast-enhanced ultrasonography after introducing Twirl breast markers
D021701
Sentinel lymph node biopsy
Sponsors
Shimazu Kenzo
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of patients who have spared axillary lymph node dissection | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactTomohiro Miyake
Osaka University Hospital
Outcome results
None listed