Theraclion U.S. BFA Trial
Breast fibroadenomas (BFA) are benign (non-cancerous) breast tumors that are comprised of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self-breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger).
BFA are the most common type of lump within the breast, affecting approximately 10% of women during their lifetime. They often appear in young women, occurring most frequently between the ages of 15 and 35. While most BFA are harmless and non-cancerous, many women consider them bothersome and wish to have them removed. Studies have shown that BFA is more common in Latin American women as compared to Caucasian women over the age of 40. In fact, BFAs are twice as common in non-white women as white women. Invasive surgery is the standard treatment, which removes the mass but leaves a scar.
Why New York-Presbyterian/Columbia?
New York-Presbyterian is one of the nation’s most comprehensive, integrated academic health care delivery systems, dedicated to providing the highest quality, most compassionate care and service to patients in the New York metropolitan area, nationally, and throughout the globe. In collaboration with two renowned medical schools, Weill Cornell Medicine and Columbia University College of Physicians and Surgeons, New York-Presbyterian is consistently recognized as a leader in medical education, groundbreaking research, and innovative, patient-centered clinical care.
Columbia University Medical Center (CUMC) is especially proud of its relationship with the surrounding Washington Heights community, many of whose members have roots in the Dominican Republic and other Spanish-speaking countries. CUMC’s Office of Government and Community Affairs serves as the primary liaison between the Medical Center and the community. Currently, CUMC has more than 40 active research and clinical programs in Northern Manhattan, including Harlem, Washington Heights, and Inwood.
Investigational Echotherapy Technology: Echopulse®
A potential alternative to invasive surgical procedures is an approach gaining more attention, called high intensity focused ultrasound (HIFU). HIFU concentrates sound waves to generate heat, much like a magnifying glass can focus light. By focusing those waves on the lumps, clinicians can destroy the tumors without cutting into the body.
The Echopulse® system is an investigational application of HIFU: A specific HIFU procedure called echotherapy with Echopulse combines therapeutic ultrasound with real-time ultrasound imaging to monitor and provide a non-invasive tumor treatment as an alternative to surgical removal.
Specifically, echotherapy uses ultrasound to guide the therapeutic beam to a targeted area, the fibroadenoma in the breast. The echotherapy procedure heats the targeted site (to 85-90°C), which causes the cells to die (tissue necrosis) and allows for the possibility to treat the fibroadenoma without the need for surgery.
Outside the U.S., Echopulse is currently indicated (with CE Mark) as the only echotherapy solution for BFA.
Scientific publications reporting on studies evaluating Echopulse for treating BFAs have shown promising results and have been published in 9 leading journals. Most recently, a study published in the Journal of Therapeutic Ultrasound demonstrated the long-term effectiveness and tolerability of Echopulse to reduce BFA volume and maintain the reduction after 24 months follow-up. Mean BFA volume was significantly reduced by 77.32% after a single Echopulse procedure and by 90.47% after two procedures at 24 months follow up.
Potential benefits of Echopulse over the surgical standard of care have the potential to include the following:
- Outpatient Procedure
- No General Anesthesia
- No Pain Post-treatment
- No Scar
- Short Procedure Time
Theraclion Technologies and Echopulse® Trial
Theraclion, which develops the Echopulse® system, is sponsoring a pivotal, multi-center U.S. trial to determine the efficacy and safety of Echopulse® echotherapy for the non-invasive treatment of breast fibroadenoma.
The trial at New York-Presbyterian/Columbia University Medical Center is being led by Dr. Margaret Chen, MD, FACS, Assistant Professor of Clinical Surgery in the Clinical Breast Cancer Program and Director of Clinical Operations at Columbia University’s Department of Surgery. Between 2009-2016, Dr. Chen has been awarded America's Top Surgeons Consumers’ Research Council of America, which is awarded to the top 10% surgeons in the U.S. Dr. Chen is currently treating patients.
The prospective clinical trial plans to enroll approximately 100 patients at four centers in the U.S., University of Virginia School of Medicine, NYU Langone Bellevue, Montefiore Medical Center (NY) and New York-Presbyterian/Columbia University Medical Center plus one site in Europe with Tübingen University Hospital, Germany.
Patients will receive a single echotherapy treatment with Echopulse®. The primary endpoint is a reduction of fibroadenoma volume, pain and anxiety at 12 months.
Participants in this study will have office visits for the initial treatment, as well as follow-up appointments at 3, 6 and 12 months to measure the volume and size of the fibroadenoma by ultrasound and physical examination. In addition, patients will provide a satisfaction questionnaire with feedback regarding pain and response at intervals up to 12 months following the treatment session.
Subjects may qualify if they:
- Are women older than 18 years of age who are not currently pregnant or nursing
- Diagnosed with breast fibroadenoma and presenting at least one palpable fibroadenoma
- The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from the skin
- The fibroadenoma is 1 cm or greater at its largest dimension and no less than 7.5 mm in the anterior-posterior dimension (measured by ultrasound).
For More Information
Interested potential participants should call Columbia University Medical Center at (212) 342-3681 for more information and potential screening.
For more information on the trial (NCT03044054), please visit: