RecruitingNot ApplicableNCT07238894

A Cohort Study of Combined Cryoablation and Thermal Ablation for Non-surgical Treatment of Breast Cancer Patients

Peking University People's Hospital Breast Surgery Department


Sponsor

Peking University People's Hospital

Enrollment

200 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Although surgical resection is the gold standard for early breast cancer treatment, some patients cannot tolerate surgery due to medical conditions or refuse surgical treatment for cosmetic reasons. In recent years, the rapid development of ablation technology has provided new directions for breast cancer patients who are not suitable for surgical treatment. Ablation uses high or low temperatures to deactivate lesions or tissues, which are gradually absorbed by the body, achieving local treatment purposes. Its safety and efficacy have been preliminarily confirmed. As an advanced minimally invasive medical device independently developed in China, the combined cryo-thermal ablation system treats tumors using a combined mode of deep cryogenic freezing and high-intensity heating. It has been approved for ablation treatment of various solid tumors including lung cancer, pancreatic cancer, kidney cancer, prostate cancer, breast cancer, bone and soft tissue sarcomas. This project proposes a prospective cohort design, based on the breast disease cohort database of Peking University People's Hospital Breast Center. It will enroll patients pathologically diagnosed with breast cancer, determined unsuitable for surgical treatment, and have received combined cryo-thermal ablation. The registered data will be used to evaluate the effectiveness and safety of percutaneous ultrasound-guided cryo-thermal composite ablation in this population.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking outcomes for breast cancer patients who are treated with a combination of two types of tumor-destroying procedures — cryoablation (freezing) and thermal ablation (heating) — instead of traditional surgery. It aims to understand how effective and safe these non-surgical approaches are. **You may be eligible if...** - You are 18 years or older with a confirmed breast cancer diagnosis - Your tumor is clearly visible on ultrasound - You cannot have surgery because you cannot tolerate anesthesia, your cancer cannot be fully removed, your cancer has spread, or you have chosen not to have surgery - You agree to the ablation procedure and have signed consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a known allergy or intolerance to cold therapy - You have a blood clotting disorder - You have an implanted electronic device (like a pacemaker) - You have incomplete medical or pathology records 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

DEVICECombined Cryoablation and Thermal Ablation system

The combined cold and heat ablation system, as an advanced minimally invasive medical device for tumors independently developed in China, adopts a combined mode of deep low-temperature cryotherapy and high-intensity heating to treat tumors. This system uses liquid nitrogen as the refrigerant, which is easy to obtain. The minimum freezing temperature can reach -196℃, and the single-needle ablation range is larger. Using anhydrous ethanol as the heat medium, the ablation needle can be heated to 80℃ after freezing, which can dissolve ice balls more quickly. At the same time, it can ablate the puncture needle tract, reduce bleeding, prevent tumor needle tract implantation and metastasis, and has higher safety.


Locations(1)

Peking University People's Hospital

Beijing, China

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NCT07238894


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