March 26, 2018
Ogden, UT — A clinical trial examining the use of cryoablation as an alternative to surgical procedures for treating primary early stage invasive breast cancer is now being conducted at Ogden Regional Medical Center.
Sanarus Technologies, developers of the Visica® 2 Treatment System, is currently sponsoring the FROST Clinical Study at Ogden Regional - the only hospital in Utah and among 14 centers across the county participating in this study.
Cryoablation also referred to as tumor freezing–uses extreme cold (cryo) to destroy diseased tissue (ablation). During the procedure, a hollow-tipped probe is placed into the tumor under ultrasound guidance. Liquid nitrogen is pumped into the probe to “spot-freeze” the lesion. The extreme cold destroys the cancer cells, which are then expelled by the body over time. The procedure generally takes about 30 minutes and is performed under local anesthesia in the hospital’s radiology suite.
Ogden Regional Medical Center offers comprehensive healthcare for every stage of a woman’s life. With Jose Perez-Tamayo, M. D., at the lead, the hospital elected to participate in 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.”
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, 14 centers are actively recruiting patients with the remaining sites identified. Patient eligibility requirements include unifocal primary invasive breast cancer diagnosed by core needle biopsy; maximum tumor size less than or equal to 1.5 cm. Cryoablation will be done with the Visica 2 Treatment System.
Early in 2016, Dr. Perez-Tamayo, was the first diagnostic radiologist in Utah to use the Visica® 2 Treatment System at Ogden Regional Medical Center as a minimally invasive alternative to lumpectomy. After achieving good clinical outcomes in the treatment of benign breast lumps, Dr. Tamayo began offering the groundbreaking nonsurgical procedure to patients with early stage breast cancer. He is now the primary investigator for the FROST Study at Ogden Regional.
“Cryoablation is a viable treatment option for many women diagnosed with early stage breast cancer,” said Perez-Tamayo. “It’s an effective alternative to surgery that involves minimal downtime and preserves the natural shape of the breast. By offering patients a virtually painless outpatient procedure, we may help relieve some of the stress related to a breast cancer diagnosis.”
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 percent ablation success in all breast tumors less than 1.0 cm and was effective in 92 percent of all targeted tumors. The Visica 2 Treatment System was the exclusive device used in the Z1072 study.
“Physicians have utilized cryoablation for decades to treat several types of cancer, most commonly kidney, liver, lung and prostate,” said Perez-Tamayo. “Cryoablation is the next step evolution for the treatment of early stage breast cancer.”
To find out how to enroll in the FROST Clinical Study at Ogden Regional Medical Center, contact Joshua Kunz, MBA, and clinical research coordinator, at 801-479-2067.