RecruitingNot ApplicableNCT07263451

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

Sponsor

Tian'an Jiang

Enrollment

24 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

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 Criteria8

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.

Interventions

DEVICEIRE by stunning pulse therapy device

Qualified patients will receive IRE ablation, followed by standard surgical resection for breast cancer.During the process, patients will be followed up and evaluated