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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

BreastMRgFUS Trial Summary

This trial is testing a new system that uses MR-guided focused ultrasound to partially ablate breast tumors in order to make them easier to remove surgically. The system is being studied for safety, tolerability, and effectiveness.

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.Check my eligibility

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.See study design

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.

BreastMRgFUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My kidney function is good, with an eGFR over 30.

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I can do all my daily activities without help.

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I am not pregnant or I have been through menopause.

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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.

BreastMRgFUS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

BreastMRgFUS 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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,655 Total Patients Enrolled

14 Trials studying Breast Cancer

7,090 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

Muse MRgFUS System (Focused Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT05291507 — Phase < 1

Breast Cancer Research Study Groups: Muse MRgFUS System

Breast Cancer Clinical Trial 2023: Muse MRgFUS System Highlights & Side Effects. Trial Name: NCT05291507 — Phase < 1

Muse MRgFUS System (Focused Ultrasound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05291507 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects have enrolled in this experiment so far?

"Affirmative. Referring to the clinicaltrials.gov website, it is clear that this research project has been recruiting since 8/2/2022 and needs 34 participants for its single-site study."

Answered by AI

Are there currently opportunities to join this research project?

"Affirmative. Data provided on clinicaltrials.gov verifies that this research effort, which was first declared on August 2nd 2022, is currently recruiting participants. A total of 34 volunteers are required to be enrolled at a single medical site."

Answered by AI

What results is this investigation aiming to attain?

"This trial will span two months with the primary goal being to count and classify instances of adverse events, device-related issues, and serious adverse reactions. Secondary aims include estimating ablation efficacy via T1-weighted non-perfused volume measurements, pathologic assessments, and MRI treatment assessment metrics concerning thermal dose."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System

2022. "Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05291507.