MR-Guided Focused Ultrasound for Breast Cancer

(BreastMRgFUS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Cindy Matsen, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Utah

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

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment MR-Guided Focused Ultrasound for Breast Cancer?

Research shows that MR-guided focused ultrasound (MRgFUS) is effective in treating both benign and malignant tumors, including breast cancer, by using heat to destroy the tumor without surgery. It has also been used successfully for pain relief in bone cancer patients, suggesting its potential for treating other types of cancer. ^{1 2 3 4 5}

Is MR-guided focused ultrasound generally safe for humans?

MR-guided focused ultrasound (MRgFUS) has been studied for various conditions, including breast cancer, bone pain, and osteoid osteoma, and has shown to be generally safe with manageable side effects in these studies. ^{1 2 5 6 7}

How is the MR-guided focused ultrasound treatment different from other breast cancer treatments?

The MR-guided focused ultrasound treatment is unique because it is a noninvasive technique that uses focused ultrasound waves to heat and destroy breast cancer tumors without surgery, unlike traditional treatments that often involve surgery, chemotherapy, or radiation. ^{1 2 4 5 8}

Research Team

Cindy Matsen, MD

Principal Investigator

Huntsman Cancer Institute

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Muse MRgFUS System (Focused Ultrasound)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided focused ultrasound surgery of breast cancer: reliability and effectiveness. [2022]

2. United States 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. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided Focused Ultrasound Versus Conventional Radiation Therapy for Painful Bone Metastasis: A Matched-Pair Study. [2017]

4. Germany 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. [2020]

5. England pubmed.ncbi.nlm.nih.gov

MR-guided focused ultrasound surgery (MRgFUS) for the palliation of pain in patients with bone metastases--preliminary clinical experience. [2022]

6. Ireland 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. [2023]

7. Greece pubmed.ncbi.nlm.nih.gov

Short-term efficacy and safety of MR-guided focused ultrasound surgery for analgesia in children with metastatic bone tumors. [2020]

8. United States 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. [2019]