Patients with benign breast tumors may be eligible for a new focused ultrasound–based investigational treatment as part of a pivotal, multi-center clinical study. The trial began last month at the University of Virginia (UVA) Medical Center.
Dr. Brenin (pictured with Dr. Carrie Rochman)
“The patient selection criteria have been updated since the pilot study,” says Dr. Brenin. “The new parameters for the size of the fibroadenoma and the range of symptoms should allow us to include more patients. Furthermore, our experience and improvements to the device have allowed us to decrease the overall treatment time.”
EchoPulse is designed to non-invasively ablate benign breast tumors using ultrasound-guided focused ultrasound treatment. Although it is not yet approved by the US Food and Drug Administration, the system received the CE Mark in Europe five years ago, where it is also used to treat breast fibroadenomas and treat thyroid nodules and is also under investigation for other conditions.
“If this multi-center trial is successful, we will seek regulatory approval in the US,” says Theraclion’s Chief Medical Officer, Michel Nuta, MD. “Approval by the FDA would allow many more women to receive precise treatment of breast fibroadenomas non-invasively and on an outpatient basis, enabling them to return to their daily lives almost immediately.”
Patients who are interested in this study at the University of Virginia (IRB# 19437) should contact Research Coordinator Katie Rea via phone (434) 243-0315 or email . More information for patients and referring physicians can also be found on the UVA website.
Dr. Brenin plans to present the initial data from the pilot study at the 18th Annual Meeting of the American Society of Breast Surgeons in Las Vegas in April 2017.
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