Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
Healthy Volunteers
NCT07238894

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

Led by Peking University People's Hospital · Updated on 2025-11-20

200

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Breast cancer confirmed by core needle biopsy
  • Tumor lesions clearly visible on ultrasound
  • No contraindications for cryoablation such as coagulation disorders
  • Unsuitable for conventional surgical resection due to intolerance to anesthesia or surgery, unresectable/metastatic disease, or patient refusal of surgery
  • Agree to undergo ablation surgery and sign consent form
Not Eligible

You will not qualify if you...

  • Missing clinical or pathological data such as imaging or pathology materials
  • Pregnant or lactating women
  • Allergies, intolerance, or contraindications to cryotherapy (e.g., cryoglobulinemia, implanted electronic devices)
  • Vulnerable populations including neurological disorders, cognitive impairments, or critically ill patients

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, China, 100000

Actively Recruiting

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Research Team

S

Shu Wang, Dr.

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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