Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
Many patients are now diagnosed with breast fibroadenomas. These are generally detected
during breast self-exams, or annual physicals as a smooth, rubbery, oval/elliptical lump in
the breast. These patients then go on to receive mammograms, sonograms and usually a core
biopsy for the differential diagnosis of benign disease (fibroadenoma) vs breast cancer.
Although fibroadenomas are benign, they can be of great concern to the patient because of
their ability to mask the presence of other lumps in the breast, they can be painful, cause
a physical deformity of the breast or have other symptoms. The current treatment is surgical
excision. Surgical removal is invasive and may be cosmetically undesirable to some patients.
It would be advantageous to develop a non-invasive ablative method for treatment of this
disease. Measures of the clinical success of patients who elect surgical removal of
fibroadenomas are generally subjective, and evaluated primarily by the patient (lack of
palpable lesion, pain free, and an acceptable cosmetic result). A non-randomized study is
proposed to allow for a more practical approach in subject recruitment. Analysis on safety
and efficacy will be performed through the use of MRI evaluation and physical exams.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
treatment/ablation of breast fibroadenoma
Clare Tempany, M.D.
Brigham and Women's Hospital
United States: Food and Drug Administration
|Brigham & Women's Hospital||Boston, Massachusetts 02115|
|Cornell Vascular||New York, New York 10022|
|University MRI||Boca Raton, Florida 33431|
|Virtua||Voorhees, New Jersey 08043|