RecruitingNot Applicable

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

United States36 participantsStarted 2022-01-19

Plain-language summary

The objective of this study is to demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for Focused Ultrasound Surgery (FUS) guidance and monitoring in patients with benign and stage 1 non-metastatic breast cancers. The investigators hypothesize that changes in HMI parameters will inform progression of FUS ablation.

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.

Inclusion Criteria: * Women age ≥18 * Patients with fibroadenoma (benign tumor) 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 the clinical care team (ideal target lesion upper boundary should be deeper than 1 cm below the skin, and the ideal size of the lesion should be 2-5 cm in diameter) Exclusion Criteria: * Pregnant or lactating women * Patients with breast implants * Patients with a history of laser or radiation therapy to the targeted breast * Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor (other than surgery) as part of clinical care

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 completion2026-05

Contact for this trial

Elisa Konofagou, PhD

212-342-0863 ek2191@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)