Study Alliance for Breast Tumor Ablation

(Haifa, Israel) is partnering with the American College of Radiology Imaging Network (ACRIN; Philadelphia, PA, USA) to enroll patients in a phase II study assessing how effectively InSightec's ExAblate 2000 technology can ablate, or destroy, cancerous breast tumors. If effective, this outpatient procedure could become a prospective non-invasive treatment alternative to lumpectomies or surgical removal of breast tumors and the surrounding area of healthy tissue.

The ExAblate 2000 combines magnetic resonance imaging (MRI) with highly-focused ultrasound to non-invasively thermally ablate tumors in the body. At present, the technology is used to treat uterine fibroids. The phase II trial is intended to demonstrate that ExAblate 2000 can effectively and non-invasively serve as the method for destruction of the localized tumor versus traditional lumpectomy. For this study, MR-guided focused ultrasound (MRgFUS) will be utilized to treat the tumor along with a margin of normal tissue. A MR scan with contrast agent will be performed 14-21 days later to assess the comprehensiveness of the treatment.

Following this, a conventional lumpectomy will be performed and the cancerous growth will be excised for pathologic assessment. The patient will receive the traditional standard of care therapy (radiation and/or chemotherapy). The pathology data will help to determine if ExAblate can destroy 95% or more of the tumor volume. A secondary endpoint will be to evaluate the ability of contrast MR to identify those patients with residual tumor post MRgFUS treatment. The study will involve 200 patients at up to 10 sites worldwide.

"We are very interested in exploring this new non-invasive technology for breast cancer, which is such a prevalent disease,” said Mitchell D. Schnall, M.D., Ph.D., associate professor of research radiology, associate chair of research, department of radiology at University of Pennsylvania (Philadelphia, PA, USA), deputy chair of ACRIN, and one of the leading investigators in this trial.





Related Links:
InSightec
ACRIN