What this Trial Is About

This is an open-label, single arm, single center, non-randomized feasibility study of the Muse MRgFUS System in subjects with breast cancer. Subjects will undergo partial ablation of half (≤50%) of one of their tumors (if multifocal or multicentric disease) followed by surgical resection per standard of care. The partial tumor ablation design will ensure that no information is lost that would impact the subject's standard of clinical care. Because current care often includes testing on the tumor, retaining a portion of viable tumor is advised by the clinical team. To ensure viable tissue confirmation, patients will be enrolled in two cohorts as described in the protocol. The investigators will use imaging correlation, histological evaluation, and subject reported outcomes to assess the safety, tolerability, and efficacy of the Muse MRgFUS System. This proposed study will adhere to the guidelines of subjects receiving a timely tumor resection after diagnosis. All subjects will undergo the definitive procedure of surgical resection per standard of care. Surgical resection cannot be delayed as a result of the ablation and should occur within 6 weeks after the decision to proceed with surgical resection. In cases where a surgery may occur outside of the 6 week window, prior approval from the external DSMC should be obtained. While MRgFUS ablation is designed to be a breast-conserving technique, the investigators will enroll patients that are undergoing any surgical resection, including both lumpectomy or mastectomy. Both surgical procedures will allow assessment of the defined primary, secondary and exploratory objectives.

Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System