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.
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.
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.
Single group
IRE by stunning pulse therapy device
DeviceQualified patients will receive IRE ablation, followed by standard surgical resection for breast cancer.During the process, patients will be followed up and evaluated
Complete ablation rate
Pathologically confirmed absence of viable tumor cells in the resected tumor bed and margins of the post-IRE surgery specimen.
Technical success rate
The technical success rate of IRE ablation followed by surgery in treating breast cancer
Incidence of Treatment-Emergent Adverse Events
The incidence and severity of all adverse events (AE) and serious adverse events (SAE)
Pain scores
Pain scores of IRE ablation. The pain intensity was assessed using the 0-10 numerical rating scale (NRS), where 0 indicates no pain and 10 indicates the most severe pain.
Imaging analysis
the ablation lesion of the imaging results of the ablation lesion after IRE.
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Tian'an Jiang
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution
