MR-Guided Focused Ultrasound for Breast Cancer

(BreastMRgFUS Trial)

Overseen By Janna Espinosa

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Utah

Disqualifiers: Other investigational agents, Prior systemic therapy, Prior radiation, Breast implants, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Muse MRgFUS System (Magnetic Resonance Guided Focused Ultrasound System) for women with invasive breast cancer who plan to undergo surgery. The researchers aim to determine if using this system to partially treat a tumor before surgery is safe and effective. The treatment targets up to half of the tumor with focused ultrasound guided by MRI, followed by the usual surgical removal of the tumor. Women with invasive breast cancer and adequate breast size for the device are suitable candidates for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Muse MRgFUS System is safe for breast cancer treatment?

Research shows that the Muse MRgFUS System is a promising tool for treating cancer. It uses sound waves, guided by MRI scans, to target and partially destroy breast tumors. Earlier studies found this system to be safe and well-tolerated by patients, with any side effects being mild and temporary, such as slight discomfort or redness at the treatment site.

The technology behind MRgFUS (Magnetic Resonance-guided Focused Ultrasound) is groundbreaking because it offers a non-surgical treatment option, often leading to fewer complications compared to traditional surgical methods.

While this treatment is still under testing, its use in clinical trials suggests it is reasonably safe. However, ongoing studies will continue to monitor its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for breast cancer, which typically involve surgery, chemotherapy, or radiation, the Muse MRgFUS System offers a non-invasive approach. This treatment uses focused ultrasound guided by MRI to target and partially ablate up to half of a tumor. Researchers are excited because this technique minimizes damage to surrounding healthy tissue and may reduce recovery time compared to traditional surgical methods. Additionally, the precision of MRI guidance ensures accurate targeting, potentially leading to better outcomes and fewer side effects.

What evidence suggests that the Muse MRgFUS System is effective for breast cancer?

Research has shown that the Muse MRgFUS System, which uses focused sound waves guided by MRI scans, can effectively reduce the size of breast cancer tumors. In this trial, participants will undergo partial ablation of up to 50% of one tumor using the Muse MRgFUS System, followed by surgical resection per standard care. This system heats and destroys part of the tumor without surgery. Early results suggest that this method can safely target and shrink breast tumors. Previous studies have indicated that MRgFUS could be a promising way to treat cancer without surgery. Although still in the early stages, this technology shows potential for conserving breast tissue. ^{1 2 3 5 6}

Who Is on the Research Team?

Cindy Matsen, MD

Principal Investigator

Huntsman Cancer Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

ASA (American Society of Anesthesiologists) Physical Status Classification Scale assessment of I-II

I went through menopause due to radiation over a year ago.

Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or

Exclusion Criteria

I've had radiation on the same breast where my current cancer is diagnosed.

Women who have breast implants.

Receiving other investigational agents at the time of study registration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo partial ablation of half (≤50%) of one of their tumors followed by surgical resection per standard of care

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of adverse events and ablation efficacy

2 months

Long-term Follow-up

Estimate disease-free survival (DFS) and overall survival (OS) at 5 years post ablation

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Muse MRgFUS System

Trial Overview 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.

How Is the Trial Designed?

Group I: Muse MRgFUS System Experimental Treatment 1 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.

Muse MRgFUS System is already approved in United States, European Union for the following indications:

Approved in United States as Muse MRgFUS System for:

• Investigational device exemption for clinical trials in human subjects with breast cancer

Approved in European Union as Muse MRgFUS System for:

• Clinical trials for breast cancer treatment

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

In a study involving 30 women with breast cancer, MRgFUS treatment resulted in an impressive average of 96.9% tumor necrosis, indicating its high effectiveness in ablating breast carcinomas.

The procedure was well tolerated with minimal adverse effects, especially when performed under local anesthesia, suggesting it could be a safe noninvasive alternative to traditional surgical methods like lumpectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided focused ultrasound surgery of breast cancer: reliability and effectiveness. Furusawa, H., Namba, K., Thomsen, S., et al.[2022]

In a study involving 24 female patients with breast carcinoma who were at increased surgical risk, MR imaging-guided focused ultrasound surgery was found to be a safe procedure, with only one minor complication reported (a second-degree skin burn).

The treatment showed promising efficacy, as 79% of patients had negative biopsy results after one or two treatment sessions, indicating successful tumor destruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of magnetic resonance imaging-guided focused ultrasound surgery as an adjunct to tamoxifen therapy in high-risk surgical patients with breast carcinoma. Gianfelice, D., Khiat, A., Boulanger, Y., et al.[2019]

Magnetic resonance-guided focused ultrasound (MRgFUS) has been shown to be an effective treatment for osteoid osteoma, achieving a high success rate of 92.8% in providing complete pain relief without recurrence in a review of 113 studies involving 353 patients.

The procedure demonstrated a low incidence of minor complications (0.85% thermal injury) and no major complications, indicating that MRgFUS is a safe noninvasive option for managing pain associated with osteoid osteoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of magnetic resonance-guided focused ultrasound for the treatment of osteoid osteoma: A systematic review and meta-analysis. Hu, R., He, P., Tian, X., et al.[2023]

Magnetic resonance-guided focused ultrasound surgery (MRgFUS) significantly reduced pain in children with metastatic bone tumors, as evidenced by lower Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) scores at multiple time points after treatment.

The procedure demonstrated high safety with no serious adverse reactions reported, and it also led to a reduction in the need for analgesics, indicating both effective pain relief and a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term efficacy and safety of MR-guided focused ultrasound surgery for analgesia in children with metastatic bone tumors. Wang, B., Li, J., Wei, X.[2020]

In a study of 63 patients with painful bone metastasis, magnetic resonance-guided focused ultrasound (MRgFUS) demonstrated a significantly higher pain relief response rate at 1 week post-treatment (71%) compared to conventional radiation therapy (RT) (26%).

While both MRgFUS and RT were effective overall, MRgFUS provided faster pain palliation, suggesting it could be a promising first-line treatment option for selected patients with bone metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided Focused Ultrasound Versus Conventional Radiation Therapy for Painful Bone Metastasis: A Matched-Pair Study. Lee, HL., Kuo, CC., Tsai, JT., et al.[2017]

In a study involving 13 patients with painful bone metastases, MRgFUS was found to be a safe procedure, with no severe adverse events reported during the 6-month follow-up period.

The treatment showed initial efficacy, as 10 out of 12 patients experienced significant pain relief and reduced need for pain medication after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided focused ultrasound surgery (MRgFUS) for the palliation of pain in patients with bone metastases--preliminary clinical experience. Catane, R., Beck, A., Inbar, Y., et al.[2022]

Magnetic resonance-guided focused ultrasound (MRgFUS) demonstrated superior accuracy in localizing nonpalpable breast lesions compared to MR-guided needle-wire placement (MRgNW), achieving a 0% rate of positive margins after excision, while MRgNW had a 25% positive margin rate.

The mean minimum tumor-free margin was significantly larger with MRgFUS (5.5 mm) compared to MRgNW (0.9 mm), suggesting that MRgFUS may provide better surgical outcomes in terms of ensuring complete removal of tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3.0-T MR-guided focused ultrasound for preoperative localization of nonpalpable breast lesions: an initial experimental ex vivo study. Schmitz, AC., van den Bosch, MA., Rieke, V., et al.[2014]

The first clinical experience with MRgFUS using the ExAblate 2100 system for non-invasive breast cancer showed promising results, with no severe adverse events reported in two patients.

Pathological examinations indicated that the treatment effectively induced tumor necrosis, suggesting that MRgFUS is a safe and feasible option for non-invasive breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative use of magnetic resonance imaging-guided focused ultrasound surgery for non-invasive breast cancer: a report of two cases. Matsutani, A., Ide, Y., Miura, S., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05291507

Feasibility Evaluation of the Muse Magnetic Resonance ... This is an open-label, single arm, single center, non-randomized feasibility study of the Muse MRgFUS System in subjects with breast cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11718996/

The Thermal Ablation with MRgFUS - PubMed Central - NIH Magnetic Resonance-guided Focused Ultrasound (MRgFUS) represents a groundbreaking advancement in ultrasound-based cancer treatments.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-04667

Muse Magnetic Resonance Guided Focused Ultrasound ... The MRgFUS System destroys part of the tumor through the use of heat from a focused ultrasound (thermal ablation) that is guided by magnetic resonance imaging ( ...

4. withpower.com withpower.com/trial/early-phase-1-breast-cancer-5-2022-af4ab

MR-Guided Focused Ultrasound for Breast Cancer 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16798487/

Magnetic resonance-guided focused ultrasound surgery ... The purpose of this study was to evaluate MRgFUS safety and effectiveness for the ablation of breast carcinomas. Study design: Thirty women with biopsy-proved ...

6. medicine.utah.edu medicine.utah.edu/radiology/research/labs-groups/fus-lab/breast-mrgfus/clinical-trials

Clinical Trials | Radiology | U of U School of Medicine MRgFUS is an ideal technology for treating breast disease with the potential for tumor destruction and excellent cosmetic results. We have pioneered a novel ...