Breast CancerEarly Phase 1BreastMRgFUSNCT05291507
Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System
A Early Phase 1 study testing Muse MRgFUS System in people with Breast Cancer, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Muse MRgFUS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2023to Aug 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Janna Espinosa, 801-585-0571, janna.espinosa@hci.utah.edu
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Muse MRgFUS System
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muse MRgFUS SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Muse MRgFUS System | Experimental | 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. Receives: Device: Muse MRgFUS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 months
Secondary outcomes (6)
Evaluate ablation efficacy by pathologic assessment
estimate ablation efficacy
Measured: 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
Measured: 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
Measured: 5 years
Evaluate ablation efficacy by MRI treatment assessment metrics of thermal dose
estimate ablation efficacy
Measured: 1 month
Evaluate ablation efficacy by T1-weighted non-perfused volume.
estimate ablation efficacy
Measured: 1 month
Evaluate how heat-induced pathways effect associations between vascular organization and immune cell infiltration.
Analysis via bulk RNA sequencing data
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start23 Jan 2023
- Primary completionJan 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, single arm, single center, non-randomized feasibility study of the Muse MRgFUS System in subjects with breast cancer.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cindy Matsen, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291507
- Sponsor's protocol ID
- HCI148669
- Acronym
- BreastMRgFUS
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System
- ClinicalTrials.gov ID
- NCT05291507
- Acronym / sponsor ID
- BreastMRgFUS / HCI148669
- Conditions
- Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single arm, single center, non-randomized feasibility study of the Muse MRgFUS System in subjects with breast cancer.
| Arm | Type | Receives |
|---|---|---|
| Muse MRgFUS System | Experimental | Device: Muse MRgFUS SystemSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muse MRgFUS SystemThe 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. | Device | Muse MRgFUS System |
Primary outcome
frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by type
Time frame: 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 severity (as defined by the NCI CTCAE, version 5.0)
Time frame: 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 seriousness
Time frame: 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 duration
Time frame: 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 relationship to the investigational intervention reported during and after the procedure as compared to baseline
Time frame: 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
6 secondary outcomes
Evaluate ablation efficacy by pathologic assessment
Time frame: 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
Time frame: 5 years
Overall survival (OS) as defined as the time from registration until death from any cause
Time frame: 5 years
Evaluate ablation efficacy by MRI treatment assessment metrics of thermal dose
Time frame: 1 month
Evaluate ablation efficacy by T1-weighted non-perfused volume.
Time frame: 1 month
Evaluate how heat-induced pathways effect associations between vascular organization and immune cell infiltration.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cindy Matsen, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Muse MRgFUS System in people with Breast Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janna Espinosa (801-585-0571, janna.espinosa@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by type (time frame: 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.