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NCT05291507 · ClinicalTrials.gov registry record · Early Phase 1
Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System
A Early Phase 1 study of Breast Cancer, sponsored by University of Utah.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT05291507: Recruiting Early Phase 1 study of Breast Cancer, sponsored by University of Utah.
NCT05291507 is a Early Phase 1 study of Breast Cancer that is actively recruiting participants, run by University of Utah. The registered enrollment target is 34 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05291507, a Early Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
evaluate the safety, feasibility, and tolerability of soft tissue ablation with the Muse MRgFUS system as assessed by subject-reported procedural pain and incidence of device- and procedure-related adverse device effects and adverse events
Conditions Studied
Interventions
- DEVICE Muse MRgFUS System
Study Locations (1)
Utah
- Huntsman Cancer Institute at University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2023-01-23 |
| Est. Completion | 2028-08 |
| Phase | Early Phase 1 |
What NCT05291507 shows while recruiting
NCT05291507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Muse MRgFUS System is the first listed.
NCT05291507 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT05291507 about?
NCT05291507 is a clinical study titled "Feasibility Evaluation of the Muse Magnetic Resonance Guided Focused Ultrasound System". 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 standar...
What is the current status of trial NCT05291507?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 34 participants. The study started on 2023-01-23. Estimated completion is 2028-08.
What conditions does trial NCT05291507 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05291507?
The interventions under investigation include: Muse MRgFUS System (DEVICE).
Who is sponsoring clinical trial NCT05291507?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05291507 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05291507's enrollment target sits among peer trials
34 928th of 1224 higher than 291 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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