Early-stage breast cancer (Tis/T1N0M0 Stage 0/I, the longest diameter <= 1.5 cm) Breast cancer
Conditions
Interventions
Intervention trial with medical device
Sponsors
Takayama shin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Ductal carcinoma (Invasive or non-invasive) diagnosed by core-needle biopsy 2)T<=1.5cm on preoperative examination (mammography, ultrasonography or magnetic resonance imaging) 3)No skin invasion and no "Delle" sign 4)No past history of neoadjuvant treatment (chemotherapy, hormonal therapy, or radiotherapy) 5)Ages 20 years or more, less than 85 years. 6)Normal organ function and tolerate postoperative radiation therapy 7)No past history of cerebral infarction, myocardial infarction and thromboembolism and tolerate general anesthesia 8)No suspicious of axillary lymph node metastasis on preoperative examination (physical examination and imaging) 9)Signed informed consent of the patient for registration 10)Ensuring that all inclusion criteria are satisfied and no exclusion criteria are met
Exclusion criteria
Exclusion criteria: 1)Pregnant women or women who are capable of pregnancy 2)Patients who had heart pacemaker or implantable cardioverter defibrillator 3)Local active inflammation and infectious disease 4)Severe complication on heart and brain 5)Patients who could not be attached electrode pads 6)Disorder of blood coagulation: due to the use of antiplatelet drug therapy or anticoagulant therapy) 7)Lesions with EIC (extensive intraductal component) or multiple lesions 8)Extensive calcifications on mammography 9)Metachronous ipsilateral breast cancer including IBTR (ipsilateral breast tumor recurrence) 10)Distant metastasis 11)Any other cases who are regarded as inadequate for study enrollment by the attending doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early adverse event incident rate (Grade 3 or more) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incomplete ablation rate, protocol completion rate | — |
Contacts
Public ContactShiino Sho
National Cancer Center Hospital
Outcome results
None listed