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.
David Brenin, MD, Associate Professor of Surgery and Chief of Breast Surgery at UVA, is the Principal Investigator for the trial. He recently completed a 20-patient pilot study to test the safety and efficacy of the device, Theraclion's EchoPulse system. Now, in this single arm prospective study, the procedure will be performed in 100 patients at several sites worldwide, including UVA, Montefiore Medical Center, Columbia Presbyterian, Bellevue Hospital Center in New York, and others. As these new sites begin treating, the list of locations will be updated on our website and on clinicaltrials.gov.
"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 [email protected] 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.