Fibroadenoma / Microbubbles / Breast Cancer Stage I · Phase 1 Trial

Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 trial registration for a novel harmonic motion imaging-guided focused ultrasound (HMIgFUS) technique combined with microbubble-mediated sonoporation for breast tumor ablation. No results have been reported in this registry record; the study is currently recruiting and aims to assess feasibility, real-time monitoring capability, and correlation between tissue stiffness changes and post-treatment immune response.

What was studied

Phase 1, Interventional, Non Randomized, Parallel, Open label, Other purpose. Fibroadenoma, Breast Cancer Stage I; Female; age from 18 Years. Intervention: HMIgFUS; HMIgLIFU. n = 82. 1 site: United States.

Key findings

Safety

Primary outcomes focus on feasibility and imaging metrics (R2 values, ablation success count), not clinical benefit or safety adverse event rates. Follow-up duration is short (approximately 1 week to pathological results); longer-term safety and oncologic outcomes are not described.

Who this may help

This trial is exploratory and does not yet provide clinical evidence for adoption of HMIgFUS technology. Results from this Phase 1 study will be needed to assess feasibility, safety, and whether the imaging-guided approach improves ablation targeting before clinical translation can be considered.

Plain-language summary

This is a Phase 1 interventional trial registration with no reported results; it describes a planned feasibility and safety study of a novel imaging-guided ablation technique in breast tumors.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Number of patients with ablation (assessed at From the date of ablation and imaging to the date of pathological results (appr…); R2 value of ablated lesion depth (assessed at From the date of ablation and imaging to the date of pathological results (appr…); R2 value of ablated lesion width (assessed at From the date of ablation and imaging to the date of pathological results (appr…); R2 value of ablated lesion area (assessed at From the date of ablation and imaging to the date of pathological results (appr…)

DesignPhase 1, Interventional, Non Randomized, Parallel, Open label, Other purpose

PopulationFibroadenoma, Breast Cancer Stage I; Female; age from 18 Years

Sample size82

InterventionHMIgFUS; HMIgLIFU

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Sample size (estimated)82

PhasePHASE 1

Primary outcome measure 1Number of patients with ablation (time frame: approximately 1 week from ablation to pathological results)

Primary outcome measure 2R2 value of ablated lesion depth (time frame: approximately 1 week from ablation to pathological results)

Primary outcome measure 3R2 value of ablated lesion width (time frame: approximately 1 week from ablation to pathological results)

Primary outcome measure 4R2 value of ablated lesion area (time frame: approximately 1 week from ablation to pathological results)

Clinical bottom line

Caveats

This is a registry record only; no trial results are reported.
Phase 1 design is not powered to demonstrate efficacy or superiority over standard care.
Primary outcomes focus on feasibility and imaging metrics (R2 values, ablation success count), not clinical benefit or safety adverse event rates.
Follow-up duration is short (approximately 1 week to pathological results); longer-term safety and oncologic outcomes are not described.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1 interventional design with defined primary outcome measures and imaging endpoints.

Directness

moderate

Direct measurement of ablation success and lesion dimensions in human breast tumors.

Consistency

insufficient

Registry record only; no results reported; consistency cannot be assessed.

Risk of bias

insufficient

No results reported; study design details insufficient to evaluate bias risk.

Sample adequacy

limited

Phase 1 design with estimated 82 participants; not powered for efficacy claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05219695). This is a study registration, not published results. Lead sponsor: Columbia University. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 82 participants (ESTIMATED). Conditions: Fibroadenoma, Breast Cancer Stage I. Interventions: PROCEDURE: Harmonic motion imaging guided focused ultrasound (HMIgFUS); PROCEDURE: Microbubble-mediated Low Intensity Focused Ultrasound (LIFU); DRUG: Microbubbles. Primary outcome measures: Number of patients with ablation , From the date of ablation and imaging to the date of pathological results (approximately 1 week); R2 value of ablated lesion depth , From the date of ablation and imaging to the date of pathological results (approximately 1 week); R2 value of ablated lesion width , From the date of ablation and imaging to the date of pathological results (approximately 1 week); R2 value of ablated lesion area , From the date of ablation and imaging to the date of pathological results (approximately 1 week). Brief summary: This study will investigate Harmonic Motion Imaging guided Focused Ultrasound (HMIgFUS) method for ablation and sonoporation monitoring of breast tumors. The aim of this study is to evaluate the efficacy of real-time guidance/monitoring and ablation/sonoporation method. The hypothesis behind this proposed study is that High Intensity Focused Ultrasound (HIFU) can be used to ablate tumor tissue, and microbubble-mediated Low Intensity Focused Ultrasound (LIFU) can be used to sonoporate tumor vasculature. The investigators of this study also hypothesize that HMI can be used to monitor HIFU ablation by measuring the changes in tissue stiffness that occur as a result of thermal ablation, guide LIFU sonoporation and HIFU ablation targeting stiff tumor tissue, and the HMI-monitored stiffness changes during ablation will correlate with post-treatment immune response. The ultimate goals of this study are: first, to assess whether these techniques can be used in the clinic in order to provide a well-monitored, noninvasive tumor ablation/sonoporation method for benign tumors and breast cancers, to minimize side effects due to invasiveness and enhance therapeutic effects of current methods; second, to make full use of the real-time monitoring capability of HMIgFUS for more precise, point-of-care treatment planning to ensure success of ablation/sonoporation and immune activation.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT05219695FibroadenomaMicrobubblesColumbia UniversityBreast Cancer Stage IHarmonic motion imaging guided focused ultrasound (HMIgFUS)Microbubble-mediated Low Intensity Focused Ultrasound (LIFU)