Safety and Feasibility of IRE for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study
NCT ID: NCT07263451
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-12-11
2026-05-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IRE and Surgical Resection
Qualified patients will receive IRE ablation, followed by standard surgical resection for breast cancer. 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.
IRE 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
Interventions
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IRE 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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Tian'an Jiang
OTHER
Responsible Party
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Tian'an Jiang
Chief Physician
Principal Investigators
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Tian'an Jiang, PhD
Role: STUDY_CHAIR
Zhejiang University
Peifen Fu, PhD
Role: STUDY_CHAIR
Zhejiang University
Locations
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Tian'an Jiang, PhD
Role: primary
Jiang
Role: primary
References
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Other Identifiers
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IREBreast
Identifier Type: -
Identifier Source: org_study_id