MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
Breast Fibroadenoma
About this trial
This is an interventional treatment trial for Breast Fibroadenoma focused on measuring Breast Cancer
Eligibility Criteria
Inclusion Criteria: Gender: Females only Histologic confirmation of breast fibroadenoma by large core (needle gauge range 11-14 ) biopsy. Single tumor per breast quadrant Tumor clearly visible on non-contrast MRI Age > 18 years 3.2.6 Signed informed consent Tumor 5 mm or larger as measured on pre-treatment MR. Exclusion Criteria: Gender: male Focal breast lesion on MRI over 3.5 cm as evaluated by MRI Distance from the edge of the breast fibroadenoma to the skin less than 0.5-cm or ribs less than 1 cm. Microcalcifications within the lesion Known intolerance to the MRI contrast agent (Gadolinium or Magnevist) 3.3.6 Patients on dialysis. Hemolytic anemia (hematocrit<30) Patients with unstable cardiac status including: Unstable angina pectoris on medication Patients with documented myocardial infarction within six months of protocol entry Congestive heart failure requiring medication (other than diuretic) Patients on anti-arrhythmic drugs Severe hypertension (diastolic BP > 100 on medication) Patients with cardiac pacemakers ASA Score>2 Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 3.3.12 Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hrs.) 3.3.13 Patients with breast implants Large patients who cannot fit in the magnet (weight>250 pounds), and patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices Patients on anti-coagulation therapy, or those with an underlying bleeding disorder. Patient has a prior history of breast cancer Patient has a prior history of laser or radiation therapy to the target breast Patient has a prior history of chemo therapy
Sites / Locations
- University MRI
- Brigham & Women's Hospital
- Virtua
- Cornell Vascular
- Breastopia Namba Hospital