Co-ablation versus cryoablation for the treatment of stage III-IV non-small cell lung cancer: A prospective, noninferiority, randomized, controlled trial (RCT).
Wuwei Yang, Yonghui An, Quanwang Li...
https://pubmed.ncbi.nlm.nih.gov/33319493Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
FEMALE
Healthy Volunteers
ID07238894
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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new minimally invasive treatment for breast cancer patients who cannot undergo surgery because of medical reasons or personal choice. This study evaluates a combined cryo-thermal ablation system, a device developed in China that uses both extreme cold and heat to destroy tumor tissue. The goal is to assess the safety and effectiveness of this treatment in patients with early breast cancer who are unsuitable for surgical removal of tumors. The treatment uses a special device that applies deep freezing with liquid nitrogen and high-intensity heating with anhydrous ethanol. This combined approach aims to destroy the breast tumor while reducing complications such as bleeding or tumor spread along the needle path. Patients receive ultrasound-guided ablation of the breast tumor, and the device’s effects are closely monitored during and after treatment. The study follows patients prospectively using a breast disease cohort database, with different groups including those who cannot have surgery due to age or health, those with advanced or metastatic disease, and those refusing surgery. Participants will undergo data collection including imaging tests like ultrasound, mammography, and MRI, plus laboratory and pathology assessments before and after ablation. Follow-up occurs every six months for at least five years, tracking outcomes such as tumor recurrence, disease-free survival, and overall survival. Safety is monitored through reporting of complications within three months after treatment. The primary focus is on local tumor control and complication rates, with additional analysis of immune response and imaging features related to recurrence risk.
CONDITIONS
Brief 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
You may qualify if you...
- Age 18 years or older
- Breast cancer confirmed by core needle biopsy
- Tumor lesions clearly visible on ultrasound imaging
- No contraindications for cryoablation such as coagulation disorders
- Unsuitable for conventional surgical resection due to intolerance to general anesthesia, unresectable or metastatic disease, or refusal of surgery
- Agree to undergo ablation surgery and sign informed consent
You will not qualify if you...
- Missing clinical or pathological data such as imaging or pathology reports
- Pregnant or lactating women
- Known allergies, intolerances, or contraindications to cryotherapy such as cryoglobulinemia or implanted electronic devices
- Vulnerable populations including those with neurological disorders, cognitive impairments, or critical illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment session with follow-up for 3 months to monitor postoperative complications
Participants receive combined cryoablation and thermal ablation to treat their breast cancer using an advanced minimally invasive device.
1 treatment visit and several follow-up visits within 3 months
Follow-up
Duration - Up to 3 years for primary and secondary outcomes, with survival follow-up extending beyond 3 years
Participants are followed for safety and effectiveness outcomes including complications, tumor recurrence, disease-free survival, and overall survival.
Follow-up visits every 6 months for at least 3 years
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.
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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