Montefiore Einstein Center for Cancer Care is now testing the efficacy and safety of a non-invasive investigative treatment for women who have the most common benign breast tumor known as a fibroadenoma (BFA).   

While non-cancerous, these tumors affect approximately 10 percent of women, appearing most frequently in Hispanic women between the ages of 15 and 35. Invasive surgery is currently the standard treatment which removes the mass but leaves a scar. 

The technology now under investigation in a pivotal U.S. trial, is called the Echopulse system, developed by Theraclion, a French echotherapy company. Echotherapy uses high intensity focused ultrasound (HIFU) waves to generate heat. By focusing these HIFU waves directly into the tumors, clinicians can potentially destroy them without cutting into the body.  

The trial at Montefiore is being led by Sheldon Feldman, M.D., Chief of the Division of Breast Surgery and Surgical Oncology, and Director of Breast Cancer Services at Montefiore Einstein Center for Cancer Care.  “We are excited to be participating in this important trial,” said Dr. Feldman.  “These tumors are so common and yet we have so few options for removing them.  The ability to offer women in the United States a new solution with the potential to prevent surgery and scarring would be a huge benefit.”  Dr. Feldman is also Immediate Past President of The American Academy of Breast Surgeons.    

The Echopulse system is currently approved for use in Europe. It was CE marked in 2012 for conforming with health, safety and environmental protection standards within the European Union. A recent trial showed at 12-month follow-up that nodules were destroyed in 90% of patients. In addition, data from the U.S. feasibility trial of Echopulse showed that the therapy was well-tolerated.

“Montefiore is the ideal place for this kind of trial,” said Dr. Feldman. “As an academic medical center, it is our role to break new ground in research while delivering patient centered care.   Anything we can do to reduce side effects with safe and effective outcomes in breast surgeries will be a welcome step forward.” 

The trial sites are currently recruiting patients. Approximately 100 women will be enrolled in the U.S.  locations.  For more information call Montefiore at 718-920-3576.