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

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

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and feasibility of irreversible electroporation (IRE) — a non-thermal energy-based technique that destroys cancer cells using electrical pulses without heat — as an alternative to surgery for small, early-stage breast cancers. **You may be eligible if...** - You are female and 18 or older - You have a confirmed diagnosis of invasive ductal carcinoma (IDC) — the most common type of breast cancer — within the past 3 months - Your tumor is 2 cm or smaller and is clearly visible on both ultrasound and MRI - You have not received any prior breast cancer treatment - You are medically fit for both surgery and general anesthesia **You may NOT be eligible if...** - Your tumor is larger than 2 cm or is multifocal (in multiple areas) - You have received prior treatment for this breast cancer - You have a pacemaker or other implanted device sensitive to electrical fields - Your tumor is not clearly visible on imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(2)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07263451


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