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Percutaneous Cryoablation for the Treatment of Breast Cancer

NCT07775014 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Ospedale Cottolengo

    lead OTHER

Principal Investigators

  • EUGENIO ZANON, MD · Ospedale Cottolengo - Breast Unit

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2029-05-31
Completion
2030-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07775014 on ClinicalTrials.gov