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

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

This is a prospective, open-label, single-arm, exploratory clinical trial conducted at our institution to investigate the use of Irreversible Electroporation (IRE) for the treatment of breast cancer.

This is a prospective, open-label, single-arm, exploratory clinical trial conducted at our institution to investigate the use of Irreversible Electroporation (IRE) for the treatment of breast cancer. Qualified patients will receive IRE ablation, followed by standard surgical resection. The efficacy and feasibility of IRE will be evaluated through statistical analysis of the outcomes, which will be recorded in accordance with the primary and secondary efficacy endpoints.

Inclusion Criteria:

1. Female, aged 18 years or older.
2. Medically fit for both surgery and general anesthesia, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
3. Treatment-naïve, primary, unifocal breast cancer with a maximum diameter of ≤ 2.0 cm as assessed by MRI.
4. Pathologically confirmed diagnosis of Invasive Ductal Carcinoma (IDC) within 3 months prior to enrollment.
5. 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).
6. The subject must be able to understand the purpose of the trial, voluntarily participate, and provide written informed consent.

Exclusion Criteria:

1. Known coagulopathy or bleeding diathesis (defined as a platelet count < 50×10⁹/L or an International Normalized Ratio (INR) > 1.5).
2. Presence of an implanted cardiac pacemaker, defibrillator, or any other active electronic medical device.
3. 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.
4. Patients who are pregnant, lactating, or planning a pregnancy during the study period.
5. Known severe allergy or anaphylactic reaction to MRI contrast agents.
6. 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.
7. Presence of distant metastases.
8. Any other medical or psychiatric condition that, in the investigator's judgment, would compromise the patient's safety or compliance with the study protocol.