Regional Medical Imaging launches national trial of new cancer treatment
FLINT — With its fourth successful procedure, Regional Medical Imaging of Flint, Mich., is helping to launch a groundbreaking multi-center clinical trial of cryoablation (exposure to extreme cold temperatures) to treat breast cancer without the trauma of surgery.
Utilizing the IceSense3 System to treat certain early stage tumors without scalpels, tissue removal or scarring, the ICE3 trial will significantly expand data on the technique. Potentially, it could usher in a new paradigm in the treatment of the disease.
According to Dr. Linsey Gold of the Michigan Center for Breast Health, who performed several of the procedures, it involves placing a small nitrogen-cooled probe into the center of a tumor to freeze it from the inside out.
“We are extremely pleased to give select women an opportunity to take advantage of the clinical and quality-of-life benefits of this treatment and to see its full promise move rapidly towards fruition,” said Dr. Randy Hicks, co-owner and CEO of RMI who is spearheading the trial. “RMI is the breast health care leader in Michigan, and clinical trials such as this give us the opportunity to move cancer treatment forward.”
The benefits of cryoablation over traditional surgical tumor removal are significant, including faster recovery, improved cosmetic results, greater patient comfort, and no need for general anesthesia or a hospital operating room, which lowers cost. Cryoablation essentially involves a nick in the skin and destroying tumors in place with minimal discomfort.
Cryoablation is well-established for treatment of liver, lung, prostate, and other cancers. Numerous, more limited studies validated its success in the treatment of breast malignancies, including a recent American College of Surgeons Oncology Group (ACOSOG) trial and extensive longterm studies in Japan.
The IceSense3 Cryoablation System™, developed by IceCure Medical (Caesarea, Israel and Memphis, Tenn.) specifically for breast applications, has a long history of successful treatment of benign breast fibroadenomas.
The ongoing refinement of cryoablation technology itself makes treatment more effective. The IceSense3 device delivers a stable cycle of extremely cold temperatures and relies on a maneuverable, disposable probe and compact, high-tech console.
The ICE3 trial is recruiting and following women aged 65 years and older diagnosed with certain tumor sub-types which measure less than 1.5 centimeters in diameter. Crafted by a diverse and esteemed scientific advisory board, the trial is underway at 20 carefully selected sites throughout the United States. IceCure will utilize its resources to provide clinical and technological support to sites in the cancer trial. — G.G.