RecruitingPhase 1

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

United States82 participantsStarted 2022-01-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Focused Ultrasound Surgery Inclusion criteria: * Women age 18 years or older with benign tumors or early-stage, non-metastatic breast cancer (stage I without the involvement of axillary lymph nodes) * Scheduled to receive surgical resection of the tumor by their clinical care team Exclusion criteria: * Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor as part of their clinical care * Pregnant or lactating * Presence of breast implants * Have a history of laser or radiation therapy to the targeted breast. Microbubble-mediated LIFU, i.e., sonoporation Inclusion criteria: * Women 18 years or older * Deemed eligible to receive neoadjuvant systemic therapy as per the treating physician, with the dose and schedule deemed appropriate by the treating physician * Any stage invasive breast cancer provided the primary breast tumor size is at least 4 mm Exclusion criteria: * Pregnant or lactating * Presence of breast implants * History of laser or radiation therapy to the affected breast * Contraindication history or hypersensitivity to ultrasound contrast agents, e.g., Definity, including polyethylene glycol (PEG) allergy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients with ablation

Timeframe: From the date of ablation and imaging to the date of pathological results (approximately 1 week)

R2 value of ablated lesion depth

Timeframe: From the date of ablation and imaging to the date of pathological results (approximately 1 week)

R2 value of ablated lesion width

Timeframe: From the date of ablation and imaging to the date of pathological results (approximately 1 week)

R2 value of ablated lesion area

Timeframe: From the date of ablation and imaging to the date of pathological results (approximately 1 week)

Trial details

NCT IDNCT05219695

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-05

Contact for this trial

Shiqi Hu, MSc

917-664-5382 sh4193@columbia.edu

View on ClinicalTrials.gov More Fibroadenoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of patients with ablation

Timeframe: From the date of ablation and imaging to the date of pathological results (approximately 1 week)

R2 value of ablated lesion depth

Timeframe: From the date of ablation and imaging to the date of pathological results (approximately 1 week)

R2 value of ablated lesion width

Timeframe: From the date of ablation and imaging to the date of pathological results (approximately 1 week)

R2 value of ablated lesion area

Timeframe: From the date of ablation and imaging to the date of pathological results (approximately 1 week)