Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System

Inclusion Criteria:

Female subjects 18 years of age or older with unilateral, unifocal invasive breast cancer undergoing lumpectomy
ECOG < 2.
ASA (American Society of Anesthesiologists) Physical Status Classification Scale assessment of I-II.
Adequate breast size for MUSE device assessed by physician prior to study enrollment.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Adequate Renal Function defined as an eGFR > 30 mL/min/1.73.
Female subjects of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.

Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:

Women < 50 years of age:

---Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and

Estradiol and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
Underwent surgical sterilization (i.e. bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).

Women ≥ 50 years of age:

Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
Had radiation-induced menopause with last menses >1 year ago; or
Had chemotherapy-induced menopause with last menses >1 year ago; or
Underwent surgical sterilization (i.e. bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).

Exclusion Criteria:

Receiving other investigational agents at the time of study registration.
Prior systemic anti-cancer therapy or any investigational therapy for neoadjuvant treatment of breast cancer.
Prior radiation therapy to the ipsilateral breast or radiation whose field(s) encompassed the breast within which the current diagnosis of cancer is made.
The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, or bladder or of the cervix). Low risk malignancies may be allowed after discussion with PI and medical monitor.
Women with breast implants
Pregnant or lactating women
Inability to lie prone for 90 minutes as reported by patient or determined by investigator assessment.
Known prior adverse reaction or allergy to commonly used sedatives (i.e. versed, propofol) (NCI CTCAE v5.0 Grade ≥ 3).
Known prior adverse reaction or allergy to gadolinium contrast (NCI CTCAE v5.0 Grade ≥ 3).
Contraindication to MRI as determined by treating phyisican or patient response on MRI patient history and safety questionnaire (Appendix 5)
Medical, psychiatric, cognitive, or other conditions in the opinion of the investigator that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.

Additional Exclusion Criteria for Cohort 1 patients only

Patient's tumor is grade 3 as determined in consulation with pathologist and treating physician.
The amount of invasive tumor in the core biopsy specimen is small as determined in consulation with pathologist and treating physician.
The resection specimen contains high-grade carcinoma that is morphologically distinct from that in the core.
Core biopsy result is equivocal for HER2 after testing by both in situ hybridization and immunohistochemistry.
There is doubt about the handling of the core biopsy specimen (long ischemic time, short time in fixative, different fixative), or the test is suspected by the pathologist to be negative on the basis of testing error.