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Brief Title: MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
Official Title: Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
Study ID: NCT00147108
Brief Summary: The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of \> 50% on palpation, and \>65% in lesion volume as measured by MRI (both calculations assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size, along with the softening of the treated volume will result in satisfactory clinical results in greater than 50 % of the patients.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
University MRI, Boca Raton, Florida, United States
Brigham & Women's Hospital, Boston, Massachusetts, United States
Virtua, Voorhees, New Jersey, United States
Cornell Vascular, New York, New York, United States
Breastopia Namba Hospital, Miyazaki-ken, , Japan
Name: Clare Tempany, M.D.
Affiliation: Brigham and Women's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Robert Min, M.D.
Affiliation: Cornell Vascular
Role: PRINCIPAL_INVESTIGATOR
Name: Fred Steinberg, M.D.
Affiliation: University MRI
Role: PRINCIPAL_INVESTIGATOR
Name: Mark DeLaurentis, M.D.
Affiliation: Virtua
Role: PRINCIPAL_INVESTIGATOR
Name: Hidemi Furusawa, M.D.
Affiliation: Breastopia Hospital
Role: PRINCIPAL_INVESTIGATOR