A multi-center clinical study to treat breast fibroadenomas with high intensity focused ultrasound (HIFU) was launched last month and is currently recruiting 100 patients in the United States. The principal investigator of this single-arm prospective study is David Brenin, MD, associate professor of surgery and chief of breast surgery at the University of Virginia (UVA) Medical Center in Charlottesville. Additional participating centers include three New York City hospitals: Bellevue Hospital Center, Montefiore Medical Center, and New York in the Bronx, New York-Presbyterian/Columbia University Medical Center.
This follows a 20-patient pilot study conducted at UVA by Dr. Brenin to test the safety and effectiveness of an ultrasound-guided HIFU system (EchoPulse®, Theraclion, Malakoff, France). The system, which an alternative to surgery, is designed to non-invasively ablate benign breast tumors by delivering a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90º C. This initiates tissue coagulation followed by tissue necrosis ablating the targeted area. Treatment may be performed on an outpatient basis.
Dr. Brenin stated that the patient selection criteria has been expanded compared to the pilot study. The criteria for women being recruited for the study include having one or more histologically confirmed palpable fibroadenomas at least 1 cm or greater at its largest dimension and no less than 7.5 mm in the anterior-posterior dimension measured by ultrasound. The fibroadenoma also should have a volume between 0.2 cc and 10 cc, and be located 5-26 mm from the skin. Women are ineligible if they have breast implants, have a calcified fibroadenoma, have a breast cyst within the fibroadenoma, or have a history of breast cancer.
The system has received CE Mark approval to treat breast fibroadenomas and thyroid nodules and has been in use in Europe for five years. If the multi-center clinical trial is successful, Theraclion will seek regulatory approval by the U.S. Food and Drug Administration (FDA).
Additional details of the clinical trial NCT NCT03044054 may be accessed here.
Clinical trial launched to assess treatment of breast fibroadenoma with HIFU. Appl Radiol.