Actively Recruiting
Safety and Feasibility of IRE for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study
Led by Tian'an Jiang · Updated on 2025-12-22
24
Participants Needed
2
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Feasibility of IRE for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 18 years or older
- Medically fit for surgery and general anesthesia with an ECOG performance status of 0-1
- Treatment-naïve, primary, unifocal breast cancer with tumor size ≤ 2.0 cm by MRI
- Pathologically confirmed invasive ductal carcinoma diagnosed within 3 months before enrollment
- Tumor is a well-defined, localized mass clearly visible on breast ultrasound and breast DCE-MRI
- Able to understand the study purpose, voluntarily participate, and provide written informed consent
You will not qualify if you...
- Known bleeding disorders or coagulopathy with platelet count < 50×10⁹/L or INR > 1.5
- Presence of implanted cardiac pacemaker, defibrillator, or other active electronic device
- History of serious cardiac disease including uncontrolled arrhythmias or NYHA Class III/IV heart failure
- Pregnant, breastfeeding, or planning pregnancy during the study period
- Severe allergy or anaphylaxis to MRI contrast agents
- Known high-risk genetic breast cancer susceptibility (e.g., BRCA1/2 mutation) increasing recurrence risk
- Presence of distant metastases
- Any other medical or psychiatric condition that may affect safety or study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
2
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
T
Tian'an Jiang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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