IceCure Medical, a developer and marketer of minimally-invasive and office-based cryoablation therapy solutions for women's health, has initiated a landmark, multi-centered, ICE3 clinical trial, designed to study the effect of percutaneous cryoablation on malignant breast tumors.
The clinical trial will recruit and follow-up on women aged 65 years or older diagnosed with luminal A breast carcinoma whose tumors measure less than 1.5cm in diameter.
These individuals will also receive adjunctive therapy based on local standards of care.
According to the company, the trial that was crafted by a diverse and esteemed scientific advisory board will be conducted at 20 carefully selected sites throughout the US.
The trial will utilize IceSense3 consoles, which are already installed for the treatment of fibroadenomas.
This announcement comes on the heels of the publication of results from Z1072 cryoablation trial.
The trial sponsored by American College of Surgeons Oncology Group (ACOSOG), involved cryoablation of small breast cancer tumors followed by traditional surgical removal.
The data collected through the ACOSOG trial resulted in some exciting finds, such as the proven success of cryoablation in destroying tumors less than 1.0 cm in diameter.
IceCure will build on that data by conducting a trial where breast cancer tumors up to 1.5 cm will be frozen, then followed over time (no surgical excision).
This trial will also utilize the more advanced IceSense3 cryoablation system that due to low, stable, cryo temperatures has the potential to completely ablate tumors up to 1.5 cm.
IceCure CEO Hezi Himelfarb said the study will employ the IceSense3 system, a third generation cryo technology that provides the coldest, fastest, most stable cryoablation treatment cycles available.
"The most exciting aspect of this trial is patients with small breast cancers will undergo cryoablation and then subsequently be monitored for the next five years. Their treatment will not require surgical excision or mastectomy," Himelfarb added.
Image: Illustration of IceSense3 Cryoablation System freezing a breast tumor. Photo: courtesy of PRNewsFoto/IceCure Medical, Inc.