Safety and Feasibility of IRE for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study

Inclusion criteria

• Female, aged 18 years or older.
• Medically fit for both surgery and general anesthesia, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Treatment-naïve, primary, unifocal breast cancer with a maximum diameter of ≤ 2.0 cm as assessed by MRI.
• Pathologically confirmed diagnosis of Invasive Ductal Carcinoma (IDC) within 3 months prior to enrollment.
• Tumor that presents as a well-defined, localized mass and is clearly visualized on both breast ultrasound (for intraoperative guidance) and breast DCE-MRI (for baseline measurement and treatment planning).
• The subject must be able to understand the purpose of the trial, voluntarily participate, and provide written informed consent.

Exclusion criteria

• Known coagulopathy or bleeding diathesis (defined as a platelet count \< 50×10⁹/L or an International Normalized Ratio (INR) \> 1.5).
• Presence of an implanted cardiac pacemaker, defibrillator, or any other active electronic medical device.
• History of significant cardiac disease, including but not limited to: uncontrolled cardiac arrhythmias or congestive heart failure classified as New York Heart Association (NYHA) Class III or IV.
• Patients who are pregnant, lactating, or planning a pregnancy during the study period.
• Known severe allergy or anaphylactic reaction to MRI contrast agents.
• Known high-risk genetic susceptibility to breast cancer (e.g., BRCA1/2 mutation carrier) associated with an increased risk of ipsilateral breast tumor recurrence following ablation.
• Presence of distant metastases.
• Any other medical or psychiatric condition that, in the investigator's judgment, would compromise the patient's safety or compliance with the study protocol.