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Feasibility Study of the Muse MRgFUS System for Breast Cancer

This study is testing a new device called the Muse MRgFUS System for women with breast cancer. This system uses focused ultrasound (sound waves) to heat and destroy a portion of a breast tumor without surgery. You would be eligible if you are a woman aged 18 or older with invasive breast cancer who is already planning to have surgery. The main goal is to see how safe the Muse MRgFUS System is by tracking any side effects or problems with the device for two months after treatment. This study is currently enrolling 34 participants.

Study design
This is a single-center study, meaning it's happening at one location, and it's not randomized. It's an open-label study, so you and your doctors will know you are receiving the Muse MRgFUS System.
What's involved
You would undergo a partial ablation (destruction) of up to half of one of your tumors using the Muse MRgFUS System, followed by standard surgical removal of the tumor. The study will track any side effects for two months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for two months to track any adverse events (side effects) or device-related issues.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05291507

Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of Utah
~34 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:Muse MRgFUS System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by type
Measured over 2 months
+4 more outcomes measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Cindy Matsen, MD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute

Who to contact

Janna Espinosa
[email protected]
801-585-0571
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
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.

What this trial measures

  • frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by type2 months

    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

  • 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)2 months

    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

  • frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by seriousness2 months

    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

  • frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by duration2 months

    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

  • 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 baseline2 months

    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