Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT05291507
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Muse MRgFUS System — DEVICE
    The intended use of the device is to thermally ablate breast tissue under magnetic resonance image guidance. The thermal ablation is performed non-invasively using extracorporeal focused ultrasound.

Study Details

This is an open-label, single arm, single center, non-randomized feasibility study of the Muse MRgFUS System in subjects with breast cancer. 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. The partial tumor ablation design will ensure that no information is lost that would impact the subject's standard of clinical care. Because current care often includes testing on the tumor, retaining a portion of viable tumor is advised by the clinical team. To ensure viable tissue confirmation, patients will be enrolled in two cohorts as described in the protocol. The investigators will use imaging correlation, histological evaluation, and subject reported outcomes to assess the safety, tolerability, and efficacy of the Muse MRgFUS System. This proposed study will adhere to the guidelines of subjects receiving a timely tumor resection after diagnosis. All subjects will undergo the definitive procedure of surgical resection per standard of care. Surgical resection cannot be delayed as a result of the ablation and should occur within 6 weeks after the decision to proceed with surgical resection. In cases where a surgery may occur outside of the 6 week window, prior approval from the external DSMC should be obtained. While MRgFUS ablation is designed to be a breast-conserving technique, the investigators will enroll patients that are undergoing any surgical resection, including both lumpectomy or mastectomy. Both surgical procedures will allow assessment of the defined primary, secondary and exploratory objectives.

Key Dates

Start date
Jan 23, 2023
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Muse MRgFUS System
    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.

Primary Outcome Measure

frequency of adverse events (AEs), adverse device effects (ADEs), and serious adverse events (SAEs) characterized by type [ Time Frame: 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute at University of UtahSalt Lake CityUtah84112
Janna Espinosa
[email protected]
801-585-0571

Find similar trials in Salt Lake City, UT

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Huntsman Cancer Institute at University of Utah· Salt Lake City, UT

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