Percutaneous Cryoablation for the Treatment of Breast Cancer

NCT07775014 | Not Yet Recruiting

• 1 other identifier: COTT-CRYO-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Breast Cancer - Infiltrating Ductal Carcinoma

Keywords

Breast Cryoablation; Percutaneous Cryoablation; Minimally Invasive Treatment; Contrast-Enhanced Mammography; Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Complete Tumor Ablation at 6 Months

  Proportion of participants with complete local tumor ablation at approximately 6 months after cryoablation. Complete ablation will be assessed by clinical examination, breast ultrasound, and contrast-enhanced mammography (CEM), with no evidence of residual viable tumor. Histologic confirmation by percutaneous biopsy will be performed only when clinical or imaging findings are suspicious or inconclusive.

  6 months after cryoablation

Secondary Outcomes (6)

• Technical Success of Cryoablation

  During the cryoablation procedure

• Procedure-Related Adverse Events

  From the cryoablation procedure through 30 days after treatment

• Residual or Recurrent Local Disease

  Up to 24 months after cryoablation

• Additional Local Treatment

  Up to 24 months after cryoablation

• Cryoablation Procedure Duration

  During the cryoablation procedure

Study Arms (1)

Ultrasound-Guided Percutaneous Cryoablation

EXPERIMENTAL

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.

Procedure: Ultrasound-Guided Percutaneous Cryoablation

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.

Ultrasound-Guided Percutaneous Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General criteria:
• Female participants aged 18 years or older.
• Histologically confirmed invasive breast carcinoma diagnosed by core needle biopsy.
• Unifocal and unilateral tumor.
• Tumor clearly visible and accessible by ultrasound.
• Tumor considered technically suitable for ultrasound-guided cryoablation, with the possibility of achieving adequate ice-ball coverage and safety margins.
• No known distant metastatic disease.
• Ability to understand the study procedures and provide written informed consent.
• Cohort A:
• \- Participants considered unsuitable for breast surgery because of age, comorbidities, or other clinical conditions, or participants who decline surgical treatment after appropriate multidisciplinary evaluation.
• Cohort B:
• Postmenopausal participants with early-stage, low-risk invasive breast cancer.
• Invasive tumor preferably 15 mm or smaller.
• Hormone receptor-positive (estrogen receptor and/or progesterone receptor positive).
• HER2-negative.

You may not qualify if:

• Multifocal or multicentric breast cancer.
• Bilateral breast cancer requiring treatment.
• Tumor not adequately visible or accessible by ultrasound.
• Tumor location or anatomy preventing safe cryoablation or achievement of an adequate ablation margin.
• Known distant metastatic disease.
• HER2-positive invasive breast cancer for Cohort B.
• Predominantly extensive intraductal disease or other findings considered unsuitable for cryoablation.
• Contraindication to the planned cryoablation procedure.
• Inability to provide informed consent or comply with study follow-up.

Sponsors & Collaborators

• Ospedale Cottolengo: lead

Study Sites (1)

Ospedale Cottolengo

Torino, TO, 10152, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• EUGENIO ZANON, MD

  Ospedale Cottolengo - Breast Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

EUGENIO ZANON, MD

CONTACT

39 3284721090; eugenio.zanon@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): November 1, 2030
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)