Pilot Study of MR-Guided Focused Ultrasound for Tissue Coagulation in Women With Breast Cancer: MR Imaging and Histopathic Correlation, An Assessment or Target Accuracy and Patient Acceptance

Brief Summary

Detailed Description

OBJECTIVES: * Determine the incidence and severity of adverse events during and after MRI-guided focused ultrasound ablation in women with stage I-IIIA breast cancer. * Determine the ability to accurately and thoroughly coagulate a target volume of breast carcinoma, in terms of real-time target volume temperature profile, follow-up MRI, and histology, using this procedure. * Compare the appearance of gross and microscopic histopathologic tissue post coagulation with the pre- and post-coagulation magnetic resonance appearance of the targeted volume and measure any residual cancer cells in patients after this procedure. * Determine patient acceptance of this procedure, in terms of positioning, pain, safety, and follow-up cosmesis. OUTLINE: This is a pilot study. Patients undergo MRI-guided focused ultrasound (MRgFUS) ablation of the breast lesion using a series of pulses. Within 72 hours after MRgFUS procedure, patients undergo gadolinium-enhanced MRI to evaluate ablation borders. Within 7-10 days after MRgFUS procedure, patients undergo an ultrasound exam. Guide wires may be placed to assist in pre-surgical lesion localization. Within 10-21 days after MRgFUS procedure, patients undergo segmental resection or mastectomy. Patients are followed at 5-10 days post-surgery. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Primary Outcomes

Not specified