Percutaneous Cryoablation for the Treatment of Breast Cancer

Sponsor
Ospedale Cottolengo
Study ID
NCT07775014
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound-Guided Percutaneous Cryoablation — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
May 31, 2029
Completion
Nov 30, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ultrasound-Guided Percutaneous Cryoablation
    Participants with localized breast cancer will undergo ultrasound-guided percutaneous cryoablation of the primary breast tumor. Treatment will be performed under local anesthesia with real-time ultrasound monitoring of the ice ball. Participants will subsequently undergo clinical and imaging follow-up according to the study protocol.

Primary Outcome Measure

Complete Tumor Ablation at 6 Months [ Time Frame: 6 months after cryoablation ]

Central Contacts

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