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Focused Ultrasound
MR-Guided Focused Ultrasound for Breast Cancer (BreastMRgFUS Trial)
Phase < 1
Recruiting
Led By Cindy Matsen, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Had radiation-induced menopause with last menses >1 year ago; or
Adequate Renal Function defined as an eGFR > 30 mL/min/1.73
Must not have
Prior radiation therapy to the ipsilateral breast or radiation whose field(s) encompassed the breast within which the current diagnosis of cancer is made
Patient's tumor is grade 3 as determined in consulation with pathologist and treating physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the Muse MRgFUS System, which uses sound waves guided by MRI to partially destroy breast tumors. It targets breast cancer patients with multiple tumor sites. The sound waves heat and kill part of the tumor while MRI ensures precise targeting. This noninvasive technique has been shown to treat both benign and malignant tumors.
Who is the study for?
This trial is for women under 50 with unilateral, unifocal invasive breast cancer planning a lumpectomy. They must be able to lie prone for 90 minutes, have no severe allergies to gadolinium contrast or sedatives, and not have had prior radiation in the affected breast or certain other cancers within the last two years. Participants should not be pregnant and must use effective contraception if of childbearing potential.
What is being tested?
The study tests the Muse MRgFUS System's safety and effectiveness in partially ablating breast tumors before surgical removal. Patients will undergo ablation of half their tumor followed by standard surgery. The trial aims to ensure that partial ablation does not delay or affect subsequent care while evaluating treatment outcomes through imaging and tissue analysis.
What are the potential side effects?
While specific side effects are not listed, they may include discomfort from lying prone during treatment, reactions to MRI contrast agents like gadolinium (if allergic), or issues related to sedation required for the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I went through menopause due to radiation over a year ago.
Select...
My kidney function is good, with an eGFR over 30.
Select...
I can do all my daily activities without help.
Select...
I am not pregnant or I have been through menopause.
Select...
I experienced menopause due to chemotherapy over a year ago.
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My hormone levels indicate I am post-menopausal.
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I have had surgery for sterilization.
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I am a woman over 18 with breast cancer having a lumpectomy on one breast.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I've had radiation on the same breast where my current cancer is diagnosed.
Select...
My tumor is classified as grade 3 by my doctor.
Select...
I cannot lie on my stomach for 90 minutes.
Select...
My HER2 test results from the biopsy are unclear.
Select...
I have had a severe allergic reaction to common sedatives.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by duration
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
frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by seriousness
+2 moreSecondary study objectives
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
Evaluate ablation efficacy by MRI treatment assessment metrics of thermal dose
Evaluate ablation efficacy by T1-weighted non-perfused volume.
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Muse MRgFUS SystemExperimental Treatment1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The Muse MRgFUS System uses focused ultrasound waves guided by magnetic resonance imaging to ablate part of the tumor tissue, offering a non-invasive approach to reduce tumor size while preserving healthy tissue. Other common treatments include surgery to remove the tumor, radiation therapy to kill cancer cells with high-energy rays, chemotherapy to target rapidly dividing cells, and hormone therapy to block hormones that fuel certain breast cancers.
These treatments are essential for managing and potentially eradicating breast cancer, providing tailored strategies based on the tumor's characteristics and the patient's condition.
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,697,765 Total Patients Enrolled
14 Trials studying Breast Cancer
7,095 Patients Enrolled for Breast Cancer
Cindy Matsen, MDPrincipal InvestigatorHuntsman Cancer Institute
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Breast Cancer
100 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had radiation on the same breast where my current cancer is diagnosed.Women who have breast implants.I went through menopause due to radiation over a year ago.My tumor is classified as grade 3 by my doctor.I have received systemic anti-cancer or investigational therapy for breast cancer before surgery.My kidney function is good, with an eGFR over 30.I am a woman aged 50 or older.I can do all my daily activities without help.I cannot lie on my stomach for 90 minutes.I am a woman under 50 years old.I am not pregnant or I have been through menopause.My HER2 test results from the biopsy are unclear.I experienced menopause due to chemotherapy over a year ago.I haven't been diagnosed with another cancer, except for low-risk types, in the last 2 years.My hormone levels indicate I am post-menopausal.I cannot have an MRI due to medical reasons.I have had surgery for sterilization.I have had a severe allergic reaction to common sedatives.I agree to use effective birth control as described.I am a woman over 18 with breast cancer having a lumpectomy on one breast.
Research Study Groups:
This trial has the following groups:- Group 1: Muse MRgFUS System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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