Clinical trial · Interventional
Percutaneous Cryoablation for the Treatment of Breast Cancer
Percutaneous Cryoablation for the Treatment of Breast Cancer: A Prospective Study of Clinical Effectiveness, Safety, and CEM-Based Imaging Surveillance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer - Infiltrating Ductal Carcinoma | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound-Guided Percutaneous Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ultrasound-Guided Percutaneous Cryoablation
- description
- 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.
- interventionNames
- Procedure: Ultrasound-Guided Percutaneous Cryoablation
Primary outcomes (1)
- measure
- Complete Tumor Ablation at 6 Months
- timeFrame
- 6 months after cryoablation
- description
- 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.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. * Histological grade 1 or 2. * Clinically node-negative disease. * Invasive carcinoma of no special type or another favorable low-risk histological subtype Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available