What is breast cryoablation?

Cryoablation uses extreme cold to destroy abnormal tissue. During the procedure, an interventional radiologist guides a thin, needle-like probe — called a cryoprobe — directly into the targeted breast lesion under live ultrasound. Liquid nitrogen or argon gas circulates through the probe, cooling its tip to temperatures below minus 170 degrees Celsius and forming a precisely shaped ice ball around the lesion.

The cold destroys the targeted tissue and a small margin of surrounding normal tissue. The destroyed cells are gradually cleared by the body’s immune system over the months that follow. Because no tissue is physically removed, breast shape is preserved, and there is typically no scarring beyond a small mark at the needle entry point.

How the procedure works

Cryoablation is performed in an outpatient procedure suite. After a local anesthetic numbs the area, a small skin nick is made and the cryoprobe is inserted under live ultrasound guidance directly into the targeted lesion. Optional mild sedation is available for comfort, but most patients remain awake.

Once the probe is in position, the freeze cycle begins. The ice ball is monitored in real time on ultrasound to ensure complete coverage of the lesion plus a safe margin. Two freeze cycles are typically performed with a brief warming pause in between. After the cycles complete, the probe is removed and the small skin entry point is bandaged. Stitches are not required.

What to expect

The treatment is delivered as a single outpatient visit, typically taking 30 to 90 minutes from the time you enter the procedure suite.

What the research shows

The largest published study of breast cryoablation for low-risk early-stage cancer is the ICE3 trial, which followed nearly 200 women treated with cryoablation plus endocrine therapy. At five years, the local recurrence rate was approximately 3 percent and 99 percent of patients rated their cosmetic outcome as satisfactory or very satisfactory.¹ Those results contributed to the FDA’s October 2025 De Novo clearance of the ProSense system for women age 70 and older with low-risk tumors who plan to receive endocrine therapy.³

Researchers are also studying whether the freezing process itself can stimulate a beneficial immune response — sometimes called the abscopal effect — in which the body’s immune system becomes better at recognizing and fighting cancer cells beyond the treated area.⁴ This remains an active area of investigation.

Who is a good candidate?

Cryoablation is not the right answer for every breast tumor. Patient selection is the most important step, and it is always made together with your breast surgical oncology and medical oncology team.² You may be a candidate if any of the following apply:

• FDA-cleared indication: Women age 70 or older with biologically low-risk, early-stage breast cancer — hormone receptor-positive, HER2-negative, low-grade tumors ≤1.5 cm — who plan to receive endocrine therapy
• Off-label use for select women age 50+: Small (≤1.5 cm), hormone receptor-positive, HER2-negative, low-grade tumors not too close to the skin or chest wall, in patients willing to take endocrine therapy
• Women not eligible for surgery: When other health conditions, age, or treatment for another cancer make surgery unsafe, cryoablation may be the most appropriate option
• Metastatic disease with a controlled primary: When systemic therapy is controlling metastases but the breast primary is progressing
• Benign fibroadenomas: FDA-approved indication, an alternative to surgical removal
• Through clinical trials: Patients outside these categories may still qualify through open studies in DCIS and other early-stage subtypes

Cryoablation tends to be less effective for larger tumors and is generally not recommended for lesions positioned very close to the skin, where the freeze zone could risk skin injury.

Who performs breast cryoablation

Breast cryoablation is performed by interventional radiologists, fellowship-trained breast imaging radiologists, and breast surgeons. The procedure depends on continuous ultrasound guidance and precise probe placement. At Florida Interventional Specialists, every procedure is delivered under live imaging and integrated into your existing breast care plan, in close coordination with the breast surgical oncology, breast imaging, and medical oncology teams across Tampa Bay.

Frequently asked questions

Is breast cryoablation FDA approved?

Yes. Cryoablation has been FDA-approved for benign fibroadenomas for years. In October 2025, the FDA cleared a specific cryoablation system (ProSense) for the local treatment of low-risk early-stage breast cancer in women age 70 and older with hormone receptor-positive, HER2-negative, low-grade tumors measuring 1.5 cm or less, who plan to receive endocrine therapy.

How is cryoablation different from a lumpectomy?

Lumpectomy is a surgical procedure that physically removes the tumor and a margin of surrounding tissue, usually under general anesthesia in an operating room. Cryoablation destroys the tumor in place using cold delivered through a small needle, under local anesthesia in an outpatient setting. Cryoablation leaves no significant scar and preserves breast shape. Lumpectomy is still the standard for most breast cancers; cryoablation is appropriate for carefully selected patients.

Will I need radiation or other treatment afterward?

For women treated under the FDA-cleared indication, endocrine therapy (such as an aromatase inhibitor or tamoxifen) is typically continued. Whether radiation therapy is needed depends on tumor biology, age, and shared decision-making with your medical and radiation oncology team. Many low-risk patients can safely omit radiation; the right answer is individual.

Will my breast look different afterward?

Because no tissue is removed, breast shape and appearance are preserved. A small area of scar tissue typically forms where the lesion was treated and may feel like a small painless lump that gradually shrinks over months. The visible scar at the needle entry point is usually only a few millimeters.

Is the procedure painful?

The procedure is performed under local anesthesia, with optional mild sedation. Most patients describe it as well tolerated. Some bruising, swelling, or tenderness is normal for several days afterward and usually responds to over-the-counter medication and ice.

References

1. Fine RE, Gilmore RC, Tomkovich KR, et al. Cryoablation Without Excision for Low-Risk Early-Stage Breast Cancer: 5-Year Results of the ICE3 Multicenter Clinical Trial. Ann Surg Oncol. 2024;31(1):66–73.
2. Mauri G, Sconfienza LM, Pescatori LC, et al. Technical success, technique efficacy and complications of minimally-invasive imaging-guided percutaneous ablation procedures of breast cancer: a systematic review and meta-analysis. Eur Radiol. 2017;27(8):3199–3210.
3. U.S. Food and Drug Administration. ProSense Cryoablation System — De Novo Clearance for Local Treatment of Low-Risk Early-Stage Breast Cancer. October 2025.
4. Sabel MS. Cryo-immunology: a review of the literature and proposed mechanisms for stimulatory versus suppressive immune responses. Cryobiology. 2009;58(1):1–11.