Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System (BreastMRgFUS)

A Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Muse MRgFUS System

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Janna Espinosa; Phone Number: 801-585-0571; Email: Janna.Espinosa@hci.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute at University of Utah
      • Contact: Janna Espinosa; Phone Number: 801-585-0571; Email: Janna.Espinosa@hci.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject is able to speak and understand English.
• Female subjects 18 years of age or older with invasive breast cancer undergoing surgery
• 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 or evidence of permanent surgical sterilization (i.e. bilateral oophorectomy, bilateral salpingectomy, or hysterectomy). The post-menopausal status will be defined as having been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:

  • Women < 50 years of age:

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

    ----Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution.

  • Women ≥ 50 years of age:

    • Amenorrhoeic 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.

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 physician or patient response on MRI patient history and safety questionnaire (Appendix 4)
• 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 consultation with pathologist and treating physician.
• The amount of invasive tumor in the core biopsy specimen is small as determined in consultation with pathologist and treating physician.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Muse MRgFUS System; 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.	Device: Muse MRgFUS System; The intended use of the device is to thermally ablate breast tissue under magnetic resonance image guidance. The thermal ablation is performed non-invasively using extracorporeal focused ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by type	evaluate the safety, feasibility, and tolerability of soft tissue ablation with the Muse MRgFUS system as assessed by subject-reported procedural pain and incidence of device- and procedure-related adverse device effects and adverse events	2 months
frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by severity (as defined by the NCI CTCAE, version 5.0)	evaluate the safety, feasibility, and tolerability of soft tissue ablation with the Muse MRgFUS system as assessed by subject-reported procedural pain and incidence of device- and procedure-related adverse device effects and adverse events	2 months
frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by seriousness	evaluate the safety, feasibility, and tolerability of soft tissue ablation with the Muse MRgFUS system as assessed by subject-reported procedural pain and incidence of device- and procedure-related adverse device effects and adverse events	2 months
frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by duration	evaluate the safety, feasibility, and tolerability of soft tissue ablation with the Muse MRgFUS system as assessed by subject-reported procedural pain and incidence of device- and procedure-related adverse device effects and adverse events	2 months
frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by relationship to the investigational intervention reported during and after the procedure as compared to baseline	evaluate the safety, feasibility, and tolerability of soft tissue ablation with the Muse MRgFUS system as assessed by subject-reported procedural pain and incidence of device- and procedure-related adverse device effects and adverse events	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate ablation efficacy by pathologic assessment	estimate ablation efficacy	1 month
Disease-free survival (DFS) as defined as the time from the date of ablation to the date of first recurrence or death from any cause	estimate disease-free survival (DFS) at 5 years post ablation	5 years
Overall survival (OS) as defined as the time from registration until death from any cause	estimate overall survival in this study population at 5 years post ablation	5 years
Evaluate ablation efficacy by MRI treatment assessment metrics of thermal dose	estimate ablation efficacy	1 month
Evaluate ablation efficacy by T1-weighted non-perfused volume.	estimate ablation efficacy	1 month
Evaluate how heat-induced pathways effect associations between vascular organization and immune cell infiltration.	Analysis via bulk RNA sequencing data	5 years

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Cindy Matsen, MD, Huntsman Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: HCI148669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes