What side effects are associated with this type of intervention?

Common treatments for breast cancer, including partial tumor ablation techniques like the Muse MRgFUS System, can have various side effects. For partial tumor ablation, side effects may include localized pain, swelling, and potential skin burns. Chemotherapy often leads to side effects such as alopecia (hair loss), fatigue, nausea, and increased risk of infections. Radiotherapy can cause skin irritation, fatigue, and in some cases, lymphedema. Hormone therapy may result in hot flashes, mood swings, and an increased risk of blood clots. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including surgical options, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. While the Muse MRgFUS System focuses on partial tumor ablation using magnetic resonance-guided focused ultrasound, similar FDA-approved treatments include radiofrequency ablation (RFA) and cryoablation. These minimally invasive techniques aim to destroy cancer cells by applying extreme heat or cold, respectively. Additionally, the FDA has approved several targeted therapies, such as trastuzumab and pertuzumab, which specifically target cancer cells with minimal damage to surrounding tissues.

What other types of research exist?

Promising novel alternatives to the Muse MRgFUS System for breast cancer treatment in 2024 include: 1) Tucatinib-capecitabine-trastuzumab regimen, particularly for HER2-positive patients with brain metastases, due to its significant overall survival benefit. 2) Fam-trastuzumab deruxtecan (T-DXd), especially for patients with stable/treated brain metastases and significant extracranial progression. 3) Trastuzumab-emtansine (T-DM1), depending on prior therapy exposure. These systemic therapies have demonstrated efficacy in both treated and untreated brain metastases and may offer comprehensive treatment options for breast cancer patients.

← Back to Search

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 below

Select...

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.

Select...

My hormone levels indicate I am post-menopausal.

Select...

I have had surgery for sterilization.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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 more

Secondary 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 more

Awards & 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.

0 / 13Eligibility criteria met

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.