Breast Cancer
Conditions
Keywords
Breast Cancer, IRE, Irreversible Electroporation
Brief 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.
Detailed description
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. Qualified patients will receive IRE ablation, followed by standard surgical resection. 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.
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
Sponsors
Tian'an Jiang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
To explore whether the irreversible electroporation can achieve the efficacy and feasibility of breast cancer.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female, aged 18 years or older. 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
1. Known coagulopathy or bleeding diathesis (defined as a platelet count \< 50×10⁹/L or an International Normalized Ratio (INR) \> 1.5). 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete ablation rate | 1 month | Pathologically confirmed absence of viable tumor cells in the resected tumor bed and margins of the post-IRE surgery specimen. |
| Technical success rate | 1 month | The technical success rate of IRE ablation followed by surgery in treating breast cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 1 month | The incidence and severity of all adverse events (AE) and serious adverse events (SAE) |
| Pain scores | 1 month | 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 | 1 month | the ablation lesion of the imaging results of the ablation lesion after IRE. |
Countries
China
Contacts
Primary ContactTian'an Jiang, PhD
Outcome results
None listed