Join a Clinical Trial

The ChoICE Trial is a follow-up study to the landmark ICE3 Trial, which contributed to FDA approval of a breast cancer cryoablation device for selected patients with early-stage breast cancer. As a condition of FDA approval, IceCure Medical, the study sponsor, is conducting this 400-patient study.

Cryoablation is performed under local anesthesia using ultrasound and a needle-like cryoprobe that freezes and kills the cancer with liquid nitrogen.

The ChoICE Trial requires a five-year course of anti-estrogen therapy after cryoablation. Radiation therapy and sentinel lymph node biopsy are optional.

A pioneer in breast cancer cryoablation with more than 20 years of clinical and research experience, Dr. Holmes is pleased to launch the first West Coast study site for this multicenter trial.

The cost of the cryoablation procedure will be billed to insurance or Medicare. If insurance does not cover the procedure, the cryoablation treatment will be provided at no cost to the patient. California residency is not required.

• Women 70 years of age or older
• Diagnosis of invasive ductal carcinoma by core needle biopsy
• A single site of disease
• Tumor size of 1.5 cm or less in greatest diameter as measured by breast ultrasound
• Estrogen receptor positive (ER+)
• Progesterone receptor positive (PR+)
• HER2 negative (HER2-)
• Favorable, low-risk tumor biology (Ki-67 less than 15%) or genomic testing showing a low risk of recurrence, such as MammaPrint or Oncotype DX

• Contact Dr. Dennis Holmes: Call 818-539-1985, Ext. 3 or email info@cryoablation.com to express your interest in participating.
• Eligibility screening: Submit your medical records, including mammograms, ultrasounds, or MRI images, for a free initial review to confirm eligibility.
• Consultation: Schedule an initial consultation, in person or via telehealth, to discuss the study and complete further assessment.
• Consent and enrollment: If eligible, you will be guided through the consent process and formally enrolled in the study.

It is my great pleasure to announce the publication of the FROST Clinical Trial, published online in the Annals of Surgical Oncology on January 15, 2026. The journal article presents and discusses the final results of the FROST Cryoablation Clinical Trial, a prospective national, multicenter study evaluating the effectiveness and safety of cryoablation for Stage I breast cancer in women age 50 and older with estrogen-sensitive, HER2-negative invasive ductal carcinoma.

All participants received anti-estrogen therapy. Radiation therapy was recommended only for women younger than 70, and lymph node surgery was optional for all participants. Dr. Dennis Holmes served as the principal investigator.

Special thanks to the pioneering women who participated in this study and made this research possible.

The FROST Study is open only for follow-up of previously treated patients. The study is not open to enrollment of additional patients.

• 5-year local recurrence rate: 3.6%, demonstrating that cryoablation is as effective as lumpectomy in appropriately selected patients.
• 5-year local recurrence rate in women age 70 and older: 2.1%.
• 97.5% of participants safely avoided lymph node surgery.
• Side effects were mild for both cryoablation and radiation therapy.
• No breast cancer-related deaths and no distant recurrences were observed.
• Anti-estrogen therapy remains essential after cryoablation, just as it is following lumpectomy.
• Radiation therapy benefits women under 70, reducing recurrence risk similarly to its role after lumpectomy.

View or download the published article.

Watch the oral presentation from the 2024 Annual Meeting of the American Society of Breast Surgeons.

This study explores cryoablation as an innovative, non-surgical treatment for ductal carcinoma in situ (DCIS). Cryoablation involves freezing the tumor using a cryoprobe, which is guided to the lesion through ultrasound. This procedure is office-based and performed under local anesthesia, minimizing the physical and psychological burden associated with traditional surgery. The primary goal is to determine if cryoablation can effectively ablate all DCIS within the targeted area, potentially offering a less invasive treatment option for patients.

• DCIS measuring 2 cm or less based on mammography or breast MRI.
• Confirmed diagnosis of DCIS through minimally invasive needle biopsy.
• No prior history of DCIS or invasive breast cancer in the same breast.
• No prior surgical biopsy or lumpectomy in the same breast.
• Adequate breast volume and skin clearance for safe cryoablation.
• Non-pregnant, non-lactating, and no pregnancy in the last 6 months.
• No history of breast radiation in the same breast.

Enrollment status: The DCIS Cryoablation Study is open only for follow-up of previously treated patients. The study is not open to enrollment of additional patients.