FROST Clinical Study for Nonsurgical Treatment of Early Stage Breast Cancer Recruiting Patients

Dr. Dennis Holmes

Cryoablation is a very promising alternative to traditional surgery for early stage breast cancer.

Sanarus Technologies, developers of the Visica® 2 Treatment System, is currently enrolling patients for the FROST clinical study, “Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer.” The FROST study is a phase II single-arm multicenter clinical trial that examines the use of cryoablation as an alternative to surgical resection for the management of primary early stage invasive breast cancer.

Cryoablation, also called percutaneous cryotherapy, is a minimally invasive treatment that uses extreme cold to destroy diseased tissue, including cancer cells. During breast cryoablation with the Visica 2 Treatment System, a hollow-tipped probe is placed into the tumor under ultrasound guidance. Liquid nitrogen passes through the probe and forms an ice ball around the lesion in a closed-loop system. The intense cold freezes the tumor, causing cell destruction. The procedure generally takes about 30 minutes and is done under local anesthesia in a physician’s office or outpatient setting. Cryoablation is often used to treat skin conditions, as well as tumors in the lungs, kidneys, prostate and liver. The primary goal of the FROST study is to determine the rate of complete tumor ablation (destruction) and absence of residual breast carcinoma as a result of treatment with cryoablation alone.

Breast cryoablation has already been shown to be a safe and effective minimally invasive alternative to lumpectomy in earlier studies. The current clinical study is a follow-up to the landmark National Cancer Institute-sponsored study “ACOSOG (Alliance) Z1072” trial which showed 100% ablation success in all breast tumors less than 1.0 cm and was effective in 92% of all targeted tumors. The Visica 2 Treatment System was the exclusive device used in the Z1072 study.

FROST investigators are actively recruiting 200 female patients, 50+ years of age, at 20 locations nationwide. The study will track the breast tumor recurrence rates, assess breast cosmesis post-treatment, record adverse events and provide 5-year follow-up. To date,…

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