Study of ExAblate Focused Ultrasound Ablation of Breast Cancer

The goal of this prospective, non-randomized, single-arm, multi site, international study is to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in the ablation of breast cancer and of MRI. The goal of MRgFUS ablation of breast cancer is to plan and ablate the entire tumor volume in a treatable and device accessible location.

Inclusion Criteria: 1. Women age 18 years with invasive breast cancer 2. Patient with contrast-enhanced MR imaging confirming a single focal breast lesion less than 2 cm in diameter 3. Lesion clearly seen on contrast-enhanced MR and in a treatable location 4. Patient who is willing to undergo and be scheduled for sentinel lymph node biopsy 5. Patient scheduled and consented to surgical (lumpectomy or mastectomy) resection of the breast cancer 6. Patient with clinical Stage I disease: T1 M0 N0 7. Patient who signs an informed consent form for screening, SLNB, ablation, and follow-up visits. Exclusion Criteria: 1. Invasive lobular carcinoma; 2. DCIS without invasive components on core biopsy; 3. Tamoxifen, Aromatase Inhibitors, and Neoadjuvant chemotherapy within 30 days prior to ExAblate. 4. Prior XRT or ablative therapy to the target breast; 5. Patients currently receiving anticoagulation therapy within the previous 14 days; 6. Lesions difficult to target (\2 15. Patient with active and ongoing infection at any body site; 16. Poor blood glucose control. 17. Severe hypertension 18. Patients with unstable cardiac status 19. Contraindication to MR or ExAblate ablation therapy 20. Patient with history of deep vein thrombosis 21. With history of pulmonary embolism; 22. Patient with sleep apnea; 23. Patient with airway problems; 24. Patient with severe claustrophobia; 25. Patient with non-MRI compatible implanted metal devices; 26. Patient with difficulty lying prone and still for up to 3 hours (180 minutes) in the MR unit; 27. Patient who cannot fit comfortably in the magnet or patients \>250 lbs; 28. Patient with prior reaction to contrast agent; 29. Patient with history of grand mal seizures; 30. Patient with severely impaired renal function with estimated glomerular filtration rate \