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Percutaneous Cryoablation for the Treatment of Breast Cancer
Sponsor: Ospedale Cottolengo
Summary
The goal of this clinical trial is to study cryoablation as a treatment for selected adults with localized breast cancer. Cryoablation uses very low temperatures to destroy the tumor through thin needles placed through the skin under ultrasound guidance. The main questions this study aims to answer are: * Can cryoablation completely destroy the treated breast tumor? * Is the procedure safe and well tolerated? * Can ultrasound and contrast-enhanced mammography be used to monitor the treated area after cryoablation? The study will include participants with breast cancer who cannot undergo surgery or choose not to have surgery, as well as selected postmenopausal participants with small, low-risk breast cancers. Participants will undergo ultrasound-guided cryoablation instead of surgical removal of the breast tumor. They will then have clinical examinations and imaging follow-up, including ultrasound and contrast-enhanced mammography, to assess the treated area over time. A biopsy will be performed if follow-up findings are suspicious or unclear. Other cancer treatments, such as radiation therapy or hormone therapy, will be given when indicated according to standard clinical practice.
Official title: Percutaneous Cryoablation for the Treatment of Breast Cancer: A Prospective Study of Clinical Effectiveness, Safety, and CEM-Based Imaging Surveillance
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-11
Completion Date
2030-11
Last Updated
2026-08-19
Healthy Volunteers
No
Interventions
Ultrasound-Guided Percutaneous Cryoablation
Percutaneous cryoablation of the primary breast tumor will be performed under local anesthesia and real-time ultrasound guidance. One or more cryoprobes will be positioned within the tumor according to lesion size and geometry. Freeze-thaw cycles will be performed to create an ice ball encompassing the tumor with an adequate safety margin, while protecting the skin and adjacent structures when necessary. Technical success and procedure-related adverse events will be recorded.
Locations (1)
Ospedale Cottolengo
Torino, TO, Italy